Publications by authors named "Jill Ohar"

61 Publications

Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease.

Int J Chron Obstruct Pulmon Dis 2022;17:79-92. Epub 2022 Jan 6.

National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.

Dry powder inhalers (DPIs) are breath actuated, and patients using DPIs need to generate an optimal inspiratory flow during the inhalation maneuver for effective drug delivery to the lungs. However, practical and standardized recommendations for measuring peak inspiratory flow (PIF)-a potential indicator for effective DPI use in chronic obstructive pulmonary disease (COPD)-are lacking. To evaluate recommended PIF assessment approaches, we reviewed the Instructions for Use of the In-Check™ DIAL and the prescribing information for eight DPIs approved for use in the treatment of COPD in the United States. To evaluate applied PIF assessment approaches, we conducted a PubMed search from inception to August 31, 2021, for reports of clinical and real-life studies where PIF was measured using the In-Check™ DIAL or through a DPI in patients with COPD. Evaluation of collective sources, including 47 applicable studies, showed that instructions related to the positioning of the patient with their DPI, instructions for exhalation before the inhalation maneuver, the inhalation maneuver itself, and post-inhalation breath-hold times varied, and in many instances, appeared vague and/or incomplete. We observed considerable variation in how PIF was measured in clinical and real-life studies, underscoring the need for a standardized method of PIF measurement. Standardization of technique will facilitate comparisons among studies. Based on these findings and our clinical and research experience, we propose specific recommendations for PIF measurement to standardize the process and better ensure accurate and reliable PIF values in clinical trials and in daily clinical practice.
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http://dx.doi.org/10.2147/COPD.S319511DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8747625PMC
March 2022

Will Remotely Based Pulmonary Rehabilitation Water Down Its Effectiveness?

Life (Basel) 2021 Nov 20;11(11). Epub 2021 Nov 20.

Department of Internal Medicine, Section on Pulmonary Medicine, Critical Care, Allergy and Immunologic Diseases, Atrium Health Wake Forest Baptist, Medical Center Boulevard, Winston-Salem, NC 27157, USA.

Despite numerous benefits, traditional Pulmonary Rehabilitation (PR) as a resource remains underutilized in chronic lung disease. Less than 3% of eligible candidates for PR attend one or more sessions after hospitalization due to many barriers, including the ongoing COVID-19 pandemic. Emerging alternative models of PR delivery such as home-based PR, tele-rehabilitation, web-based PR, or hybrid models could help address these barriers. Numerous studies have tested the feasibility, safety, and efficacy of these methods, but there is wide variability across studies and methods. We conducted a literature review to help determine if these alternative delivery methods watered down the effectiveness of PR. To evaluate the effectiveness of remotely based PR, the authors performed a literature search for randomized controlled trials (RCTs), cohort studies, and case series using PubMed, CINAHL, and Medline to identify relevant articles through 1 May 2021. Twenty-six applicable studies were found in which 11 compared tele-rehabilitation to conventional clinic-based PR; 11 evaluated tele-rehabilitation using the patient's baseline status as control; and four compared tele-rehabilitation to no rehabilitation. Despite the different technologies used across studies, tele-rehabilitation was found to be both a feasible and an efficacious option for select patients with lung disease. Outcomes across these studies demonstrated similar benefits to traditional PR programs. Thus the existing data does not show that remotely based PR waters down the effectiveness of conventional PR. Use of remotely based PR is a feasible and effective option to deliver PR, especially for patients with significant barriers to conventional clinic-based PR. Additional, well-conducted RCTs are needed to answer the questions regarding its efficacy, safety, cost-effectiveness and who, among patients with COPD and other lung diseases, will derive the maximum benefit.
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http://dx.doi.org/10.3390/life11111270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8625237PMC
November 2021

Novel LRRK2 mutations and other rare, non-BAP1-related candidate tumor predisposition gene variants in high-risk cancer families with mesothelioma and other tumors.

Hum Mol Genet 2021 08;30(18):1750-1761

Cancer Epigenetics and Signaling Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA.

There is irrefutable evidence that germline BRCA1-associated protein 1 gene (BAP1) mutations contribute to malignant mesothelioma (MM) susceptibility. However, BAP1 mutations are not found in all cases with evidence of familial MM or in other high-risk cancer families affected by various cancers, including MM. The goal of this study was to use whole genome sequencing (WGS) to determine the frequency and types of germline gene variants occurring in 12 MM patients who were selected from a series of 141 asbestos-exposed MM patients with a family history of cancer but without a germline BAP1 mutation. WGS was also performed on two MM cases, a proband and sibling, from a previously reported family with multiple cases of MM without the inheritance of a predisposing BAP1 mutation. Altogether, germline DNA sequencing variants were identified in 21 cancer-related genes in 10 of the 13 probands. Germline indel, splice site and missense mutations and two large deletions were identified. Among the 13 MM index cases, 6 (46%) exhibited one or more predicted pathogenic mutations. Affected genes encode proteins involved in DNA repair (ATM, ATR, BRCA2, BRIP1, CHEK2, MLH3, MUTYH, POLE, POLE4, POLQ and XRCC1), chromatin modification (ARID1B, DNMT3A, JARID2 and SETD1B) or other cellular pathways: leucine-rich repeat kinase 2 gene (LRRK2) (two cases) and MSH4. Notably, somatic truncating mutation or deletions of LRRK2 were occasionally found in MMs in The Cancer Genome Atlas, and the expression of LRRK2 was undetectable or downregulated in a majority of primary MMs and MM cell lines we examined, implying that loss of LRRK2 expression is a newly recognized tumor suppressor alteration in MM.
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http://dx.doi.org/10.1093/hmg/ddab138DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411985PMC
August 2021

The Role of ICS/LABA Fixed-Dose Combinations in the Treatment of Asthma and COPD: Bioequivalence of a Generic Fluticasone Propionate-Salmeterol Device.

Pulm Med 2021 17;2021:8881895. Epub 2021 Mar 17.

Viatris/Mylan Pharma UK Ltd., UK.

Both asthma and chronic obstructive pulmonary disease (COPD) are inflammatory chronic respiratory conditions with high rates of morbidity and mortality worldwide. The objectives of this review are to briefly describe the pathophysiology and epidemiology of asthma and COPD, discuss guideline recommendations for uncontrolled disease, and review a new generic option for the treatment of asthma and COPD. Although mild forms of these diseases may be controlled with as-needed pharmacotherapy, uncontrolled or persistent asthma and moderate or severe COPD uncontrolled by bronchodilators with elevated eosinophilia or frequent exacerbations may require intervention with combination therapy with inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs), according to international guidelines. Fixed-dose combinations of ICS/LABA are commonly prescribed for both conditions, with fluticasone propionate (FP) and salmeterol forming a cornerstone of many treatment plans. An oral inhalation powder containing the combination of FP and salmeterol has been available as Advair Diskus® in the United States for almost 20 years, and the first and only substitutable generic version of this product has recently been approved for use: Wixela™ Inhub™. Bioequivalence of Wixela Inhub and Advair Diskus has been established. Furthermore, the Inhub inhaler was shown to be robust and easy to use, suggesting that Wixela Inhub may provide an alternative option to Advair Diskus for patients with asthma or COPD requiring intervention with an ICS/LABA.
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http://dx.doi.org/10.1155/2021/8881895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7994080PMC
January 2022

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®.

Pulm Ther 2020 Dec 18;6(2):289-301. Epub 2020 Aug 18.

Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.

Introduction: Personalized therapy for patients with COPD requires appropriate choice of drug and delivery device. Inhalers and nebulizers vary in their drug delivery characteristics, particularly the need for passive or active patient inhalation for appropriate drug dispersal and delivery. In this in vitro analysis, we assessed the aerosol performance and drug delivery of two long-acting muscarinic antagonists, glycopyrrolate (GLY; 25 µg solution; 1 ml) and tiotropium (TIO; 18 µg powder) through their respective delivery systems: the eFlow® Closed System (CS) vibrating membrane nebulizer and the HandiHaler® dry-powder inhaler (DPI).

Methods: The aerosol performances of the eFlow® CS nebulizer and the HandiHaler® were determined using the Next Generation cascade Impactor. The delivered dose of GLY and TIO was determined using different breathing patterns, which varied in tidal volume and peak inspiratory flow rate, respectively, to simulate breathing conditions ranging from normal to severe obstruction.

Results: Aerodynamic particle analysis showed generally similar mass median aerodynamic diameter (MMAD, range, 3.6-4.6 µm) and fine particle fraction (FPF, range, 48.2%-63.7%) with GLY delivered using the eFlow® CS nebulizer under all breathing patterns tested. TIO, delivered via the HandiHaler®, showed variations in MMAD (range, 3.8-5.8 µm) and FPF (range, 16.1%-32.4%) under different inspiratory flow rates. The majority of GLY was deposited in stages 2-5 of the impactor, which corresponds with particle sizes in the respirable range (< 5 µm), whereas a large proportion of TIO was deposited in the throat/mouthpiece pre-separator, irrespective of test conditions. The median residual dose of GLY with eFlow® CS was notably lower compared to that of TIO with HandiHaler® (2.4%-4.4% vs. 40%-67%, respectively).

Conclusions: These simulation results highlight the different deposition patterns generated by a DPI device and a vibrating membrane nebulizer, which may help inform device selection and treatment decision in COPD management.
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http://dx.doi.org/10.1007/s41030-020-00125-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672140PMC
December 2020

Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline.

Am J Respir Crit Care Med 2020 08;202(4):e74-e87

Noninvasive ventilation (NIV) is used for patients with chronic obstructive pulmonary disease (COPD) and chronic hypercapnia. However, evidence for clinical efficacy and optimal management of therapy is limited. Patients with COPD, clinicians who care for them, and policy makers. We summarized evidence addressing five PICO (patients, intervention, comparator, and outcome) questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to evaluate the certainty in evidence and generate actionable recommendations. Recommendations were formulated by a panel of pulmonary and sleep physicians, respiratory therapists, and methodologists using the Evidence-to-Decision framework. ) We suggest the use of nocturnal NIV in addition to usual care for patients with chronic stable hypercapnic COPD (conditional recommendation, moderate certainty); ) we suggest that patients with chronic stable hypercapnic COPD undergo screening for obstructive sleep apnea before initiation of long-term NIV (conditional recommendation, very low certainty); ) we suggest not initiating long-term NIV during an admission for acute-on-chronic hypercapnic respiratory failure, favoring instead reassessment for NIV at 2-4 weeks after resolution (conditional recommendation, low certainty); ) we suggest not using an in-laboratory overnight polysomnogram to titrate NIV in patients with chronic stable hypercapnic COPD who are initiating NIV (conditional recommendation, very low certainty); and ) we suggest NIV with targeted normalization of Pa in patients with hypercapnic COPD on long-term NIV (conditional recommendation, low certainty) This expert panel provides evidence-based recommendations addressing the use of NIV in patients with COPD and chronic stable hypercapnic respiratory failure.
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http://dx.doi.org/10.1164/rccm.202006-2382STDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427384PMC
August 2020

Pharmacotherapy for Chronic Obstructive Pulmonary Disease: Molecules and Delivery Are Equally Important.

Am J Respir Crit Care Med 2020 11;202(10):1482

University of North Carolina School of Medicine Chapel Hill, North Carolina.

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http://dx.doi.org/10.1164/rccm.202004-1489LEDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667917PMC
November 2020

Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.

Int J Chron Obstruct Pulmon Dis 2020 6;15:995-1004. Epub 2020 May 6.

Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.

Purpose: The clinical manifestation of COPD can differ by gender, with women experiencing worse lung function and health-related quality of life than men. Additionally, women tend to report more symptoms given the same disease severity. Accordingly, the impact of gender on efficacy and safety in patients with moderate-to-very-severe COPD was examined following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily (BID) or placebo.

Patients And Methods: GLY and placebo pooled data from the replicate 12-week GOLDEN 3 and 4 studies (n=861) were grouped by gender. Endpoints reported were change from baseline in trough forced expiratory volume in 1 second (FEV), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores. Safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs.

Results: Men (placebo: 54.7%; GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β-agonists or inhaled corticosteroids. GLY treatment resulted in significant, clinically important improvements in trough FEV, regardless of gender. Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women. Although EXACT-RS improved in both genders, only women experienced a significant improvement. Overall, GLY was well tolerated with a numerically lower incidence of AEs in men than women.

Conclusion: Treatment with nebulized GLY resulted in lung function, SGRQ total score, and EXACT-RS total score improvements regardless of gender. However, only EXACT-RS showed significantly greater improvements in women compared with men. Treatment with GLY was generally well tolerated across genders. These data support the efficacy and safety of GLY 25 µg BID in patients with moderate-to-very-severe COPD, independent of gender. Gender similarities in airflow improvement and differences in symptom-reporting augment the evidence supporting the consideration of individualized treatment plans for COPD patients.
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http://dx.doi.org/10.2147/COPD.S240303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212992PMC
June 2021

Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.

Chest 2020 10 25;158(4):1413-1419. Epub 2020 Apr 25.

Theravance Biopharma US, Inc., South San Francisco, CA. Electronic address:

Background: Peak inspiratory flow (PIF) has been proposed as a measure to assess a patient's ability to use dry powder inhalers (DPIs). However, robust quality criteria to determine a repeatability limit for measuring PIF are lacking.

Research Questions: What are the repeatability limits for measuring PIF? What is the relationship between PIF measured using the In-Check DIAL device at Diskus (GlaxoSmithKline; PIF) and HandiHaler (Boehringer Ingelheim; PIF) resistances?

Study Design And Methods: Data from a randomized, controlled, phase 3 trial (study 0149; see Clinical Trial Registration data) were used to define repeatability limits for PIF. In addition, a model to characterize the relationship between PIF measured with the In-Check DIAL device at PIF and PIF was defined using data from two randomized, controlled, phase 3 trials (studies 0128 and 0149).

Results: In study 0128, the mean values (SD) for PIF at zero resistance and PIF were 84.6 (33.4) and 57.3 (26.1) L/min, respectively. In study 0149, the mean values (SD) for PIF and PIF were 42.4 (11.2) and 29.0 (8.3) L/min, respectively. At the mean level, the mean difference between measurement attempts for PIF and PIF was small, < 5 and < 3 L/min, respectively. The repeatability limit was determined as 10 and 5 L/min for PIF and PIF, respectively. Modeling the relationship between PIF and PIF, after controlling for significant covariates, demonstrated that a PIF value of 60 L/min was approximately equivalent to PIF of 40 L/min.

Interpretations: This analysis demonstrated that the two highest values of PIF using the In-Check DIAL device among three inspiratory efforts, met the repeatability limit. Altogether, these data provide guidance for measuring PIF against the simulated resistance of a specific DPI in clinical practice and research studies.

Clinical Trial Registration: ClinicalTrials.gov; Nos.: NCT02518139 (study 0128) and NCT03095456 (study 0149); URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2020.03.072DOI Listing
October 2020

The Role of Guaifenesin in the Management of Chronic Mucus Hypersecretion Associated with Stable Chronic Bronchitis: A Comprehensive Review.

Chronic Obstr Pulm Dis 2019 Oct;6(4)

Internal Medicine & Pulmonology, Charlotte Lung & Health Center, Charlotte, North Carolina.

Chronic obstructive pulmonary disease is the third leading cause of death and disease burden worldwide. It includes a spectrum of diseases including chronic bronchitis which is characterized by overproduction, hypersecretion and decreased elimination of mucus. Chronic bronchitis has numerous clinical consequences, including predisposition to lower respiratory tract infections, accelerated decline in lung function, increased exacerbation rate and decreased health-related quality of life.

Although the inflammatory mechanisms responsible for mucus cell metaplasia in chronic obstructive pulmonary disease and stable chronic bronchitis are poorly understood, the main goals of therapy are to decrease mucus hypersecretion by controlling inflammation and to increase mucus clearance. Non-pharmacological measures include smoking cessation and chest physiotherapy. Pharmacological interventions include expectorants and mucolytics together with long-acting beta2-adrenergic receptor agonists, anticholinergics, glucocorticoids, phosphodiesterase-4 inhibitors, antioxidants, and antibiotics.

Guaifenesin is an expectorant that is thought to increase hydration and decrease viscosity of mucus leading to improved clearance of accumulated secretions from the upper and lower airway. Although guaifenesin has a Food and Drug Administration Over-the-Counter (OFC) Monograph indication to "help loosen phlegm (mucus) and thin bronchial secretions in patients with stable chronic bronchitis," there is limited published evidence of either mechanism of action or clinical efficacy in this disease state. Here we review the pathophysiology and consequences of chronic mucus hypersecretion and examine the evidence for the use of guaifenesin in patients with stable chronic bronchitis.
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http://dx.doi.org/10.15326/jcopdf.6.4.2019.0139DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006698PMC
October 2019

Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate.

Chronic Obstr Pulm Dis 2019 Oct;6(4)

Theravance Biopharma US, Inc., South San Francisco, California.

Background: Patients with chronic obstructive pulmonary disease (COPD) and suboptimal peak inspiratory flow rate (sPIFR) may not benefit optimally from dry powder inhalers (DPI) because of inadequate inspiratory flow. Nebulized bronchodilators may provide a better alternative. We compared bronchodilation with the long-acting muscarinic antagonist (LAMA) revefenacin for nebulization versus the DPI LAMA tiotropium, in patients with COPD and sPIFR (< 60 L/min against the resistance of Diskus®).

Methods: This was a randomized, double-blind, double-dummy, 28-day Phase 3b study in patients with COPD enrolled based on sPIFR. The primary endpoint was trough forced expiratory volume in 1 second (FEV) on Day 29 for revefenacin for nebulization versus tiotropium HandiHaler® DPI.

Results: We enrolled 206 patients with mean (standard deviation) age, 65 (8) years; percent predicted FEV, 37 (16)%; PIFR, 45 (12) L/min. In the intent-to-treat (ITT) population, revefenacin improved trough FEV from baseline; however, the difference versus tiotropium was not significant (least squares [LS] mean difference [standard error], 17.0 [22.4] mL, P=0.4461). In a prespecified analysis of patients with FEV < 50% predicted, revefenacin produced an LS mean difference (95% confidence interval [CI]), 49.1 (6.3-91.9) mL in trough FEV and 103.5 (7.7-199.3) mL in forced vital capacity versus tiotropium. Revefenacin produced >100 mL increase in FEV in 41.6% versus 34.4% of patients with tiotropium in ITT and 41.4% versus 25.7% of patients in FEV < 50% predicted populations.

Conclusions: Revefenacin did not produce significant improvements in FEV1 versus tiotropium in the ITT population, but increased trough FEV in patients with FEV < 50% predicted and sPIFR. Clinical Trial Registration (www.Clinicaltrials.gov): Study 0149 (NCT03095456).
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http://dx.doi.org/10.15326/jcopdf.6.4.2019.0137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006701PMC
October 2019

Efficacy of Indacaterol/Glycopyrrolate in Patients with COPD by Airway Reversibility at Baseline: A Pooled Analysis of the FLIGHT1 and FLIGHT2 12-Week Studies.

COPD 2019 04 27;16(2):133-139. Epub 2019 Jun 27.

b Sunovion Pharmaceuticals Inc. , Marlborough , MA , USA.

Bronchodilator reversibility occurs in patients with COPD. Pooled analysis of two 12-week, placebo-controlled randomised studies (FLIGHT1 [NCT01727141]; FLIGHT2 [NCT01712516]) assessed the effect of bronchodilator reversibility on lung function, patient-reported outcomes, and safety in 2,043 patients with moderate-to-severe COPD treated with indacaterol/glycopyrrolate (IND/GLY) 27.5/15.6 µg twice daily. Reversibility was defined as post-bronchodilator increase in forced expiratory volume in one second (FEV) of ≥12% and ≥0.200 L. Overall, mean reversibility (mean post-bronchodilator FEV increase) was 22.8%, and 54.5% of patients met reversibility criteria. IND/GLY resulted in significant ( < 0.05) placebo-adjusted improvements from baseline at Week 12 in reversible and non-reversible patients in FEV area under the curve from 0 to 12 hours (0.308 L and 0.170 L, respectively), trough FEV (0.260 L and 0.174 L), St. George's Respiratory Questionnaire total score (-6.3 and -3.5), COPD Assessment Test total score (-2.3 and -1.2), daily rescue medication use (-1.52 and -0.79), and daily total symptom score (-0.86 and -0.63); Transition Dyspnoea Index focal score also showed improvements (1.93 and 1.29) at Week 12, irrespective of reversibility status. Improvements in lung function and rescue medication use were significantly ( < 0.05) greater in IND/GLY patients in the reversible subgroup compared with the non-reversible subgroup. The safety profile was similar across treatment groups and reversibility subgroups. Overall, treatment with IND/GLY led to significant improvements in lung function and PROs in patients with moderate-to-severe COPD, regardless of reversibility status, with greater improvements in the reversible subgroup. Safety profile was not affected by reversibility status.
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http://dx.doi.org/10.1080/15412555.2019.1612341DOI Listing
April 2019

Preoperative Sleep Questionnaires Identify Medical Emergency Team Activation in Older Adults.

J Am Med Dir Assoc 2019 10 11;20(10):1340-1343.e2. Epub 2019 Jun 11.

Department of Internal Medicine, Section of Pulmonary, Critical Care and Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC.

Patients with obstructive sleep apnea (OSA) have increased postoperative complications that are important for patient safety and healthcare utilization. Questionnaires help identify patients at risk for OSA; however, among older adults who preoperatively self-administered OSA questionnaires, the frequency of postoperative Medical Emergency Team Activation (META), rapid response, code blue, code stroke, is unknown.

Objectives: Identify whether having OSA questionnaires completed by patients is feasible in the preoperative clinic. Determine the frequency of META among older patients at risk for OSA.

Design And Intervention: Cohort of prospective patients independently completed 2 OSA questionnaires in a preoperative clinic, STOP-Bang (SB) and ISNORED (IS). Observers blinded to questionnaire responses recorded incidence of META.

Setting And Participants: Of the 898 consecutive patients approached in the preoperative assessment clinic and surgical navigation center, 575 (64%) consented and completed the questionnaires in <5 minutes and were included in the analysis.

Measures: Sleep questionnaire responses and frequency of inpatient postoperative META.

Results: With an affirmative response to ≥3 questions on either questionnaire, 65% of patients enrolled were at risk for OSA. Of these, 3.1% sustained an META. In patients at risk for OSA, META occurred in 7.6% (SB+) and 7.2% (IS+) vs 2.5% (SB+) and 1.7% (IS+) for low risk. METAs were disproportionately higher among patients aged ≥65 years (6.3% vs 1.7%; P < .018), American Society of Anesthesiologists (ASA) physical status class ≥3, and IS+. All patients with META positively answered ≥3 of 15 components of the 2 questionnaires.

Conclusions/implications: Preoperative, self-administration of SB and IS questionnaires is feasible. Overall, 65% of those with affirmative responses to ≥3 questions were at risk for OSA and associated with a disproportionate number of postoperative META in older patients. Additionally, risk of OSA identified by preoperative sleep questionnaires was associated with postoperative META among older adults. Use of clinical tools and OSA questionnaires may improve preoperative identification of META in this population.
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http://dx.doi.org/10.1016/j.jamda.2019.04.024DOI Listing
October 2019

Prevalence and factors associated with suboptimal peak inspiratory flow rates in COPD.

Int J Chron Obstruct Pulmon Dis 2019;14:585-595. Epub 2019 Mar 1.

Division of Pulmonary Diseases and Critical Medicine, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA,

Purpose: Adequate peak inspiratory flow rate (PIFR) is required for drug dispersion with dry powder inhalers (DPIs). Prevalence of PIFR discordance (suboptimal PIFR with prescribed inhalers) and factors influencing device-specific PIFR are unclear in COPD. The objective of this study was to determine the prevalence of PIFR discordance and associated clinical factors in a stable COPD population.

Patients And Methods: An observational, single-center, cohort study was conducted including 66 outpatients with COPD. PIFR was measured using the In-Check™ Dial with applied resistance of prescribed inhalers. Participants were defined as discordant if measured PIFR was <30 L/min and <60 L/min for high and low-medium resistance devices, respectively, using an inspiratory effort the participant normally used with their prescribed DPI.

Results: The median age of the COPD participants was 69.4 years, 92% were white and 47% were female. A total of 48% were using low-medium resistance DPIs (Diskus/Ellipta) and 76% used high-resistance DPI (Handihaler). A total of 40% of COPD participants were discordant to prescribed inhalers. Female gender was the only factor consistently associated with lower PIFR. Shorter height was associated with reduced PIFR for low-medium resistance (=0.44; =0.01), but not high resistance (=0.20; =0.16). There was no correlation between PIFR by In-Check™ dial and PIFR measured by standard spirometer.

Conclusion: PIFR is reduced in stable COPD patients, with female gender being the only factor consistently associated with reduced PIFR. Discordance with prescribed inhalers was seen in 40% of COPD patients, suggesting that many COPD patients do not generate adequate inspiratory force to overcome prescribed DPIs resistance in the course of normal use.
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http://dx.doi.org/10.2147/COPD.S195438DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402615PMC
July 2019

Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of GEM1 and GEM2 12-week studies.

Int J Chron Obstruct Pulmon Dis 2019;14:461-470. Epub 2019 Feb 19.

Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.

Purpose: Bronchodilator reversibility has been reported in patients with COPD, although correlations between reversibility and treatment response are unclear. The effect of reversibility on lung function, health status, and dyspnea was assessed in patients with moderate-to-severe COPD receiving glycopyrrolate (GLY) 15.6 µg twice daily vs placebo in the Glycopyrrolate Effect on syMptoms and lung function 1 and 2 (GEM1 and GEM2) replicate, 12-week, placebo-controlled studies.

Patients And Methods: Reversibility was defined as a post-bronchodilator increase of ≥12% and ≥0.200 L in FEV. FEV area under the curve from 0 to 12 hours (AUC0-12 h), trough FEV, St George's Respiratory Questionnaire (SGRQ) total score, COPD Assessment Test (CAT™) score, Transition Dyspnea Index (TDI) focal score, daily symptom scores, and rescue medication use were assessed by reversibility status. Incidences of adverse events and serious adverse events were also assessed.

Results: Data from 846 patients enrolled in GEM1 and GEM2 with known reversibility status were pooled for post hoc analysis. GLY significantly improved FEV AUC0-12 h, trough FEV, SGRQ and CAT total scores, and rescue medication use compared with placebo in reversible and nonreversible patients. Significant improvements in TDI focal score and daily symptom scores with GLY over placebo were observed only among reversible patients. Improvements in FEV AUC0-12 h (0.165 vs 0.078 L; <0.001) and trough FEV (0.173 vs 0.070 L; <0.001) were clinically relevant (based on minimal clinically important differences) and significantly greater in reversible compared with nonreversible patients receiving GLY. The safety profile of GLY was not affected by reversibility status.

Conclusion: In this post hoc analysis, GLY was associated with significant improvements in lung function and patient-reported outcomes compared with placebo, mostly independent of reversibility status. In patients receiving GLY, improvements in lung function were greater in reversible compared with nonreversible patients. Reversibility status did not meaningfully impact the safety profile of GLY.
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http://dx.doi.org/10.2147/COPD.S194102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388797PMC
July 2019

Use of a Cross-Sectional Survey in the Adult Population to Characterize Persons at High-Risk for Chronic Obstructive Pulmonary Disease.

Healthcare (Basel) 2019 Jan 18;7(1). Epub 2019 Jan 18.

Division of Pulmonary, Critical Care and Sleep Medicine, Medical University of South Carolina, Charleston, SC 29425, USA.

Rationale/Objective: The Behavioral Risk Factor Surveillance System (BRFSS) health survey has been used to describe the epidemiology of chronic obstructive pulmonary disease (COPD) in the US. Through addressing respiratory symptoms and tobacco use, it could also be used to characterize COPD risk.

Methods: Four US states added questions to the 2015 BRFSS regarding productive cough, shortness of breath, dyspnea on exertion, and tobacco duration. We determined COPD risk categories: provider-diagnosed COPD as self-report, high-risk for COPD as ≥10 years tobacco smoking and at least one significant respiratory symptom, and low risk was neither diagnosed COPD nor high risk. Disease burden was defined by respiratory symptoms and health impairments. Data were analyzed using multiple logistic regression models with age as a covariate.

Results: Among 35,722 adults ≥18 years, the overall prevalence of COPD and high-risk for COPD were 6.6% and 5.1%. Differences among COPD risk groups were evident based on gender, race, age, geography, tobacco use, health impairments, and respiratory symptoms. Risk for disease was seen early where 3.75% of 25⁻34 years-old met high-risk criteria. Longer tobacco duration was associated with an increased prevalence of COPD, particularly >20 years. Seventy-nine percent of persons ≥45 years-old with frequent shortness of breath (SOB) reported having or being at risk of COPD, reflecting disease burden.

Conclusion: These data, representing nearly 18% of US adults, indicates those at high risk for COPD share many, but not all of the characteristics of persons diagnosed with the disease and demonstrates the value of the BRFSS as a tool to define lung health at a population level.
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http://dx.doi.org/10.3390/healthcare7010012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6473439PMC
January 2019

Efficacy and safety of a novel, nebulized glycopyrrolate for the treatment of COPD: effect of baseline disease severity and age; pooled analysis of GOLDEN 3 and GOLDEN 4.

Int J Chron Obstruct Pulmon Dis 2019;14:27-37. Epub 2018 Dec 18.

Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.

Background: The efficacy and safety of nebulized glycopyrrolate inhalation solution (GLY), administered twice daily (BID) via the innovative eFlow Closed System nebulizer (PARI Pharma GmbH, Starnberg, Germany), were demonstrated in two replicate, placebo-controlled, 12-week Phase III studies (GOLDEN 3 and GOLDEN 4). This report evaluates the efficacy and safety of GLY by baseline disease severity and age in the pooled GOLDEN 3 and GOLDEN 4 patient population (N=1,294).

Methods: Patients were grouped by baseline predicted post-bronchodilator FEV (<50%, ≥50%) and age (<65, ≥65, ≥75 years).

Results: GLY (25 and 50 μg BID) produced significant improvements in trough FEV in FEV% predicted <50% (0.070 L, 0.079 L) and ≥50% (0.112 L, 0.126 L) subgroups (<0.01 vs placebo), and in patients aged <65 (0.056 L, 0.086 L), ≥65 (0.140 L, 0.124 L), and ≥75 (0.144 L, 0.120 L) years (<0.05 vs placebo). St George's Respiratory Questionnaire (SGRQ) total score was significantly improved with GLY 25 and 50 μg BID (<0.05 vs placebo) in FEV% predicted <50% (-3.237, -3.061) and ≥50% (-3.392, -2.322) and in <65 years (-3.447, -2.318) and ≥65 years (-3.053, -3.098) subgroups. In patients aged ≥75 years, GLY 25 μg reduced SGRQ total score by -6.278 units (<0.01 vs placebo). The incidence of treatment-emergent adverse events was similar between GLY and placebo across all subgroups, and the overall incidence of cardiovascular events was low.

Conclusions: Nebulized GLY improved lung function and health status and was well tolerated over 12 weeks in patients with moderate-to-very-severe COPD, irrespective of baseline disease severity and age.

Clinical Trial Registration: NCT02347761, NCT02347774.
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http://dx.doi.org/10.2147/COPD.S184808DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305132PMC
July 2019

Asthma-Chronic Obstructive Pulmonary Disease Overlap: Diagnostic and Management Challenges.

J Fam Pract 2018 10;67(10 Suppl):S46-S51

Department of Baccalaureate and Graduate Nursing, Eastern Kentucky University, Richmond, KY, USA.

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October 2018

Spirometry in Hospitalized Patients with Acute Exacerbation of COPD Accurately Predicts Post Discharge Airflow Obstruction.

Chronic Obstr Pulm Dis 2018 Apr 1;5(2):124-133. Epub 2018 Apr 1.

Department of Pulmonary and Critical Care, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.

Objective documentation of airflow obstruction is often lacking inhospitalized patients treated for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The utility of spirometry performed in hospitalized patients to identify airflow obstruction, and thus a diagnosis of COPD, is unclear. Our aim was to compare inpatient spirometry, performed during an AECOPD, with outpatient spirometry. A retrospective analysis of data from patients enrolled in an AECOPD care plan was performed. As part of the plan, patients underwent inpatient spirometry to establish a COPD diagnosis and outpatient clinic spirometry within 4 weeks of hospital discharge to confirm it. Data analyzed included forced expiratory volume in 1 second (FEV), forced vital capacity (FVC), slow vital capacity (SVC) and FEV/ vital capacity (VC). Obstruction was defined by FEV/VC<0.70. A total of 159 patients (mean age 63.2 +/- 10.5 years) had corresponding in- and outpatient spirometry. The median days between inpatient and outpatient spirometry was 12 (interquartile range [IQR] 9-16). Inpatient spirometry had a sensitivity of 94%, specificity of 24%, positive predictive value of 83% and negative predictive value of 53% for predicting outpatient obstruction. The area under curve for using inpatient spirometry was 0.82. The mean difference between inpatient and outpatient FEV was 0.44 +/- 0.03 liters or 17.3 +/- 1.13 % predicted (<0.0001) for FEV. Inpatient spirometry accurately predicts outpatient airflow obstruction, thus providing an opportunity to identify patients admitted with suspected AECOPD who have no prior spirometric documentation.
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http://dx.doi.org/10.15326/jcopdf.5.2.2017.0169DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190522PMC
April 2018

The Role of Inhalation Delivery Devices in COPD: Perspectives of Patients and Health Care Providers.

Chronic Obstr Pulm Dis 2018 Apr 1;5(2):111-123. Epub 2018 Apr 1.

Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.

Inhaled medications form the foundation of pharmacologic treatment for chronic obstructive pulmonary disease (COPD).The Delivery Makes a Difference (DMaD) project was conducted to better understand health care provider (HCP) and patient perspectives about the role of inhalation delivery devices in COPD, and to examine the nature of educational efforts between HCPs and patients on proper device technique. Data were derived from 2 original quantitative, web-based, descriptive, cross-sectional surveys distributed to HCPs who manage COPD (n=513) and patients with COPD (n=499) in the United States. Descriptive statistics were used to assess data across important demographic variables. Inferential statistics were used to assess differences in attitudinal, descriptive, and behavioral measures that were cross-tabulated with demographic data. When prescribing medication for newly diagnosed patients with stable or unstable COPD, only 37% of HCPs considered type of device to be highly important, with only 45% of HCPs assessing device technique in every newly diagnosed patient. Patients with COPD were also relatively unconcerned with proper device technique (64% never concerned), regardless of their COPD severity. Although patients did not identify education as a significant impediment to proper device use, they reported inconsistent educational experiences. We found that HCPs and patients prioritize medication over device when selecting treatments, showing limited concerns about proper device use. These results highlight the need to coordinate professional education with patient-directed educational efforts to further promote proper device selection and use in COPD management.
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http://dx.doi.org/10.15326/jcopdf.5.2.2017.0168DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190525PMC
April 2018

Results of a Pulmonologist Survey Regarding Knowledge and Practices With Inhalation Devices for COPD.

Respir Care 2018 07 1;63(7):840-848. Epub 2018 May 1.

University of Tennessee, Knoxville, Tennessee.

Background: COPD guidelines advise on inhaled medication use, yet no advice is offered on when to use and which type of patient could benefit from a specific delivery device. We investigated pulmonologists' perception of their knowledge and practices with delivery devices for COPD management.

Methods: An online survey was designed by a steering committee of American Thoracic Society clinicians and scientists and conducted by a national market research firm between January 7 and 29, 2016.

Results: Two hundred and five respondents completed the survey. Nearly 80% of the respondents believed that they were very knowledgeable in COPD management and the use of medications; 68% believed that they were knowledgeable about preventing exacerbations. Ninety-eight percent of the respondents stated that they were at least somewhat knowledgeable about devices. Many respondents (70%) stated that small-volume nebulizers were more effective than dry powder inhalers and pressurized metered-dose inhalers in the management of COPD exacerbations, and 63% believed that these were more effective in severe COPD (modified Medical Research Council dyspnea scale grade 4). Only 54% of the respondents discussed device options with their patients. Physician screening for physical or cognitive impairments that could impact device choices was 53% and 16%, respectively. Seventy percent of the respondents discussed device use, whereas 9% discussed cleaning and storage during a patient's first visit. Few respondents were very knowledgeable in teaching patients how to use devices (43%) and, specifically, how to use (32%) or clean and/or maintain (20%) small-volume nebulizers.

Conclusions: Most respondents were confident in their knowledge about treating COPD. Fewer respondents were confident about the use and maintenance of inhalation devices, and most respondents desired to learn more about inhalation devices.
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http://dx.doi.org/10.4187/respcare.05717DOI Listing
July 2018

Results of a Patient Survey Regarding COPD Knowledge, Treatment Experiences, and Practices With Inhalation Devices.

Respir Care 2018 07 20;63(7):833-839. Epub 2018 Mar 20.

Icahn School of Medicine at Mount Sinai, New York, New York.

Background: Successful inhalation therapy depends on the ability of patients with COPD to properly use devices. We explored subjects' COPD knowledge, including education they receive from health care providers, treatment experiences, and practices with inhalation devices.

Methods: A multiple-choice online survey, developed by a steering committee of American Thoracic Society clinicians and scientists, was administered to subjects with COPD who were sourced from the Harris Poll Online panel.

Results: Of the 254 respondents (mean age 61.8 y; 49% males), most subjects (82%) claimed to understand their disease and available treatments, yet COPD symptoms and causes were well known to only 45% and 44% of subjects, respectively. Forty-three percent of subjects had ever used a pressurized metered-dose inhaler or dry-powder inhaler. Of the 54% of subjects who had ever used a small-volume nebulizer (SVN), 63% considered this device to be easy to use, 55% considered it to be fast-acting, 53% considered it to be convenient, and 38% considered it to be essential for treatment. Among subjects who had ever used them, SVNs were preferred by 54% over other devices. One third of subjects desired more extensive education during office visits; 25% felt the time was insufficient to cover questions, and 15% felt their concerns about COPD treatment(s) were ignored. Subjects believed physicians (32%), nurses (26%), and no single provider (28%) were primarily responsible for training and assessing proper inhalation technique.

Conclusion: The survey showed differences between patients' beliefs and knowledge of COPD; the need for continuous education from health care providers, particularly on inhalation devices; and extensive use of pressurized metered-dose inhalers and dry-powder inhalers despite positive perceptions of SVNs.
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http://dx.doi.org/10.4187/respcare.05715DOI Listing
July 2018

Peak Inspiratory Flow Rate in Chronic Obstructive Pulmonary Disease: Implications for Dry Powder Inhalers.

J Aerosol Med Pulm Drug Deliv 2017 Dec 21;30(6):381-387. Epub 2017 Sep 21.

1 Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States with a significant economic burden related to hospital admissions for exacerbations. One of the primary treatment modalities for COPD is medications delivered through breath-actuated dry powdered inhalers (DPIs). For users to successfully receive inhaled medication, they must inhale with enough flow to overcome the internal resistance of the device, leading to deaggregation of the medication powder. Peak inspiratory flow rate (PIFR) is the maximal flow rate obtained during an inspiratory maneuver. PIFR measurement can be impacted by the internal resistance of the device, which varies with device design. Many devices require a PIFR >60 L/min for adequate medication dispersal, while others appear to have adequate drug deaggregation with a PIFR >30 L/min. Studies have shown PIFRs are reduced among females and decrease with age, without a clear correlation between forced expiratory volume in 1 second and PIFR. PIFR can be reduced at the time of COPD exacerbation. Recent data suggest that reduced PIFR may be associated with worse COPD-related symptom burden, increased odds of COPD-related hospital readmissions, and improved responsiveness to nebulized therapy. This review article aims to examine the physiology and clinical correlations of PIFR, as well as review published studies related to PIFR with DPIs used to treat COPD.
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http://dx.doi.org/10.1089/jamp.2017.1416DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5915227PMC
December 2017

Personalization of Device Therapy - Prime Time for Peak Inspiratory Flow Rate.

Chronic Obstr Pulm Dis 2017 Jul 14;4(3):172-176. Epub 2017 Jul 14.

Section of Pulmonary, Critical Care, Allergy and Immunology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.

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http://dx.doi.org/10.15326/jcopdf.4.3.2017.0155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5556908PMC
July 2017

Guiding Principles for the Use of Nebulized Long-Acting Beta2-Agonists in Patients with COPD: An Expert Panel Consensus.

Chronic Obstr Pulm Dis 2016 Nov 15;4(1):7-20. Epub 2016 Nov 15.

David Geffen School of Medicine at the University of California, Los Angeles.

Determining which patients with COPD may benefit from a nebulized long-acting beta2-agonist (LABA) is a challenge in current practice. In the absence of strong clinical guidelines addressing this issue, an expert panel convened to develop guiding principles for the use of nebulized LABA therapy in patients with COPD. This article summarizes these guiding principles and other practical issues discussed during a roundtable meeting.
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http://dx.doi.org/10.15326/jcopdf.4.1.2016.0141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560246PMC
November 2016

Medicare Bundled Payments for Care Improvement Initiative for Chronic Obstructive Pulmonary Disease Readmissions: A Negative Study That Has Positive Implications.

Authors:
Jill A Ohar

Ann Am Thorac Soc 2017 05;14(5):617-618

Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

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http://dx.doi.org/10.1513/AnnalsATS.201701-011EDDOI Listing
May 2017

Acute Cytomegalovirus (CMV) Infection Associated with Hemophagocytic Lymphohistiocytosis (HLH) in an Immunocompetent Host Meeting All Eight HLH 2004 Diagnostic Criteria.

Cureus 2017 Mar 2;9(3):e1070. Epub 2017 Mar 2.

Department of Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest University Baptist Medical Center.

Hemophagocytic lymphohistiocytosis (HLH) is a rare and often deadly syndrome characterized by severe inflammation and cytokine dysregulation. The disease is defined by the HLH-2004 criteria, requiring five of eight findings, and is further differentiated into either primary or secondary causes. Primary HLH tends to be of genetic etiology, while secondary HLH results from other insults such as infection. Secondary HLH is most commonly associated with viral infections in immunocompromised patients. Acute cytomegalovirus (CMV) associated HLH in the immunocompetent host is exceedingly rare and only documented in four case reports to date. We describe the fifth documented case of CMV-associated HLH in an immunocompetent patient, and furthermore, we demonstrate that this patient is the first published case of its type to satisfy all eight of HLH-2004 criteria.
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http://dx.doi.org/10.7759/cureus.1070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5376153PMC
March 2017

Suboptimal Inspiratory Flow Rates Are Associated with Chronic Obstructive Pulmonary Disease and All-Cause Readmissions.

Ann Am Thorac Soc 2017 Aug;14(8):1305-1311

Wake Forest School of Medicine Medical Center, Winston Salem, North Carolina.

Rationale: Dry powder inhalers (DPIs) are prescribed after hospitalization for acute exacerbation of COPD (AECOPD). Peak inspiratory flow (PIF) affects DPI delivery.

Objectives: To study the impact of PIF on readmission after hospitalization for AECOPD.

Methods: A retrospective analysis of hospitalized patients, enrolled in an AECOPD care plan, was performed. Data analyzed included PIF, age, sex, length of stay, Charlson Comorbidity Index, COPD Assessment Test score, modified Medical Research Council score, percent predicted FEV, FVC, and inspiratory capacity. A PIF equal to and less than 60 L/min was defined as suboptimal (sPIF). Outcome measures included 30- and 90-day COPD and all-cause readmissions, and days to next COPD and all-cause readmissions.

Results: Of the 123 subjects, 52% (n = 64) had sPIF. They had greater COPD Assessment Test scores (29.1 ± 5.9 vs. 25.3 ± 8.7; P = 0.0073), rates of 90-day COPD readmissions (28.1 vs. 13.6%; P = 0.048), fewer median days to COPD (63.5 [interquartile range (IQR), 21-89.8] vs. 144 [IQR, 66-218]; P = 0.002) and all-cause readmissions (65.5 [IQR, 24.3-107.3] vs. 101 [IQR, 54.5-205.5]; P = 0.009). PIF was the only variable (P = 0.041) that predicted days to COPD readmission in a multivariate model incorporating age, sex, percent predicted FEV, Charlson Comorbidity Index, and inspiratory flow group. In a group of patients with sPIF (n = 22), all-cause and COPD 30- and 90-day readmission rates were significantly lower for those discharged with nebulizer compared with DPI therapy.

Conclusions: sPIF is common during AECOPD and predicts all-cause and COPD readmissions. Patients with sPIF may benefit from nebulized therapies. We recommend checking PIF in patients hospitalized for AECOPD for selection of delivery devices.
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http://dx.doi.org/10.1513/AnnalsATS.201611-903OCDOI Listing
August 2017

A retrospective study of two populations to test a simple rule for spirometry.

BMC Fam Pract 2016 06 4;17:65. Epub 2016 Jun 4.

University of North Carolina Chapel Hill, Chapel Hill, NC, USA.

Background: Chronic lung disease is common and often under-diagnosed.

Methods: To test a simple rule for conducting spirometry we reviewed spirograms from two populations, occupational medicine evaluations (OME) conducted by Saint Louis and Wake Forest Universities at 3 sites (n = 3260, mean age 64.14 years, 95 % CI 58.94-69.34, 97 % men) and conducted by Wake Forest University preop clinic (POC) at one site (n = 845, mean age 62.10 years, 95 % CI 50.46-73.74, 57 % men). This retrospective review of database information that the first author collected prospectively identified rates, types, sensitivity, specificity and positive and negative predictive value for lung function abnormalities and associated mortality rate found when conducting spirometry based on the 20/40 rule (≥20 years of smoking in those aged ≥ 40 years) in the OME population. To determine the reproducibility of the 20/40 rule for conducting spirometry, the rule was applied to the POC population.

Results: A lung function abnormality was found in 74 % of the OME population and 67 % of the POC population. Sensitivity of the rule was 85 % for an obstructive pattern and 77 % for any abnormality on spirometry. Positive and negative predictive values of the rule for a spirometric abnormality were 74 and 55 %, respectively. Patients with an obstructive pattern were at greater risk of coronary heart disease (odds ratio (OR) 1.39 [confidence interval (CI) 1.00-1.93] vs. normal) and death (hazard ratio (HR) 1.53, 95 % CI 1.20-1.84) than subjects with normal spirometry. Restricted spirometry patterns were also associated with greater risk of coronary disease (odds ratio (OR) 1.7 [CI 1.23-2.35]) and death (Hazard ratio 1.40, 95 % CI 1.08-1.72).

Conclusions: Smokers (≥ 20 pack years) age ≥ 40 years are at an increased risk for lung function abnormalities and those abnormalities are associated with greater presence of coronary heart disease and increased all-cause mortality. Use of the 20/40 rule could provide a simple method to enhance selection of candidates for spirometry evaluation in the primary care setting.
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http://dx.doi.org/10.1186/s12875-016-0467-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4893220PMC
June 2016

Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA.

Int J Chron Obstruct Pulmon Dis 2016 15;11:785-97. Epub 2016 Apr 15.

Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality, and health care expenditure worldwide. Relaxation of airway smooth muscle with inhaled bronchodilators is the cornerstone of treatment for stable COPD, with inhaled corticosteroids reserved for those with a history of exacerbations. Tiotropium has occupied center stage in COPD treatment for over 10 years and improves lung function, quality of life, exercise endurance, and reduces the risk of COPD exacerbation. Long-acting β2-agonists (LABAs) improve lung function, reduce dynamic hyperinflation, increase exercise tolerance, health-related quality of life, and reduce acute exacerbation of COPD. The combination of long-acting muscarinic antagonists (LAMAs) and LABAs is thought to leverage different pathways to induce bronchodilation using submaximal drug doses, increasing the benefits and minimizing receptor-specific side effects. Umeclidinium/vilanterol is the first combination of LAMA/LABA to be approved for use in stable COPD in USA and Europe. Additionally, indacaterol/glycopyrronium and aclidinium/formoterol have been approved in Europe and in numerous locations outside USA. Several other agents are in the late stages of development, most of which offer once-daily dosing. The benefits of new LAMA/LABA combinations include improved pulmonary function, dyspnea, and health-related quality of life, and in some cases, reduced exacerbations. These evolving treatments will provide new opportunities and challenges in the management of COPD.
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http://dx.doi.org/10.2147/COPD.S54513DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4841398PMC
January 2017
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