Publications by authors named "William Storms"

40 Publications

Improved lung function and quality of life following guaifenesin treatment in a patient with chronic obstructive pulmonary disease (COPD): A case report.

Respir Med Case Rep 2018 25;24:84-85. Epub 2018 Apr 25.

SRxA Strategic Pharmaceutical Advisors, 1750 Tysons Boulevard, Suite 1500, McLean, VA 22102, USA.

We report improved lung function and quality of life following daily use of guaifenesin/dextromethorphan (Mucinex DM, Reckitt Benckiser) for the treatment of mucus-related symptoms in a patient with COPD, who presented with increasing dyspnea, progressive cough and chest congestion.
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http://dx.doi.org/10.1016/j.rmcr.2018.04.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6010616PMC
April 2018

Daily use of guaifenesin (Mucinex) in a patient with chronic bronchitis and pathologic mucus hypersecretion: A case report.

Respir Med Case Rep 2018 25;23:156-157. Epub 2018 Feb 25.

SRxA Strategic Pharmaceutical Advisors, 1750 Tysons Boulevard, Suite 1500, McLean, VA 22102, USA.

We report an improvement in symptoms and quality of life with long-term use of guaifenesin for the treatment of mucus-related symptoms in a patient with chronic bronchitis, who presented with mucus hypersecretion, cough and dyspnea.
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http://dx.doi.org/10.1016/j.rmcr.2018.02.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925951PMC
February 2018

Exercise-induced bronchoconstriction update-2016.

J Allergy Clin Immunol 2016 11 21;138(5):1292-1295.e36. Epub 2016 Sep 21.

The first practice parameter on exercise-induced bronchoconstriction (EIB) was published in 2010. This updated practice parameter was prepared 5 years later. In the ensuing years, there has been increased understanding of the pathogenesis of EIB and improved diagnosis of this disorder by using objective testing. At the time of this publication, observations included the following: dry powder mannitol for inhalation as a bronchial provocation test is FDA approved however not currently available in the United States; if baseline pulmonary function test results are normal to near normal (before and after bronchodilator) in a person with suspected EIB, then further testing should be performed by using standardized exercise challenge or eucapnic voluntary hyperpnea (EVH); and the efficacy of nonpharmaceutical interventions (omega-3 fatty acids) has been challenged. The workgroup preparing this practice parameter updated contemporary practice guidelines based on a current systematic literature review. The group obtained supplementary literature and consensus expert opinions when the published literature was insufficient. A search of the medical literature on PubMed was conducted, and search terms included pathogenesis, diagnosis, differential diagnosis, and therapy (both pharmaceutical and nonpharmaceutical) of exercise-induced bronchoconstriction or exercise-induced asthma (which is no longer a preferred term); asthma; and exercise and asthma. References assessed as relevant to the topic were evaluated to search for additional relevant references. Published clinical studies were appraised by category of evidence and used to document the strength of the recommendation. The parameter was then evaluated by Joint Task Force reviewers and then by reviewers assigned by the parent organizations, as well as the general membership. Based on this process, the parameter can be characterized as an evidence- and consensus-based document.
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http://dx.doi.org/10.1016/j.jaci.2016.05.029DOI Listing
November 2016

The impact of expired and empty quick-relief asthma inhalers: The Asthma and Allergy Foundation of America's Asthma Inhaler Design Survey.

Allergy Asthma Proc 2015 Jul-Aug;36(4):300-5. Epub 2015 Apr 27.

William Storms Allergy Clinic, Colorado Springs, Colorado, USA.

Background: Despite the available treatments, asthma remains a serious illness, with a considerable socioeconomic burden associated with a high number of unscheduled visits to the emergency department (ED). Poor adherence and inadequate inhaler technique are contributing factors to poor asthma management and control.

Objective: The Asthma Inhaler Design Survey assessed the behaviors, attitudes, needs, and preferences of patients with asthma and their caregivers with regard to quick-relief inhaler usage and device design.

Methods: The Asthma and Allergy Foundation of America invited 19,157 adult patients and parents of children with asthma to take part in an online survey that focused on previous asthma diagnosis, symptom severity, and quick-relief and controller medication use. Opinions were also collected.

Results: Data from 590 respondents (366 adults; 224 children) were included in the final analysis. Relief inhalers were needed and found to be past the expiration date by 284 of 561 (50.6%) and relief inhalers were found to be empty by 270 of 560 (48.2%). Of the empty inhaler group, 28 of 270 (10.4%) had to visit the ED for treatment, 18 of 270 (6.7%) missed work or school for an unscheduled physician office visit, and 54 of 270 (20%) went without treatment. Although 78.5% indicated that they had at least two quick-relief inhalers nearby, these were not always easily accessible. Few respondents (194/578 [33.6%]) indicated that they and/or their child were very confident that they were using their inhaler properly, even though the majority had received some instruction. When asked what they would do to improve satisfaction with their quick-relief inhalers, 173 of 558 (31%) responded that they would add a dose counter.

Conclusion: Unnecessary health care utilization and avoidable loss of time at work or school were associated with the lack of full availability of properly functioning quick-relief inhalers when needed. Adding a dose counter was the most frequently cited response for improving satisfaction with quick-relief inhalers. Confidence about proper inhaler use was low, despite previous instruction.
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http://dx.doi.org/10.2500/aap.2015.36.3854DOI Listing
March 2016

Recommendations for the pharmacologic management of allergic rhinitis.

Allergy Asthma Proc 2014 May-Jun;35 Suppl 1:S20-7

Allergic rhinitis (AR) affects at least 60 million people in the United States each year, resulting in a major impact on patient quality of life, productivity, and direct and indirect costs. As new therapies, data, and literature emerge in the management of AR, there is a need to communicate and disseminate important information to health care professionals to advance the practice of medicine and lessen the disease burden from AR. Treatment recommendations for AR have not been updated since the 2012 Food and Drug Administration approval of nonaqueous intranasal aerosol agents using hydrofluoroalkane propellants and the first aqueous intranasal combination product. Here, we present an updated algorithm for the pharmacologic treatment of AR that includes these new treatment options. Treatment recommendations are categorized by disease severity (mild versus moderate/severe) and duration of symptoms (episodic versus nonepisodic, with episodic defined as <3 days/wk or for <3 weeks). Preferred treatments are suggested, as well as alternative options for consideration by clinicians in the context of individual patient needs. This recommendation article also outlines the importance of treatment monitoring, which can be conducted using the recently developed Rhinitis Control Assessment Test. Successful therapeutic outcomes depend on multiple factors, including use of the most effective pharmacologic agents as well as patient adherence to therapy. Therefore, it is imperative that rhinitis patients not only receive the most effective therapeutic options, but that they also understand and are able to adhere to the comprehensive treatment regimen. Successful treatment, with all of these considerations in mind, results in better disease outcomes, improved quality of life for patients, and greater economic productivity in the home and workplace.
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http://dx.doi.org/10.2500/aap.2014.35.3761DOI Listing
September 2015

New intranasal formulations for the treatment of allergic rhinitis.

Allergy Asthma Proc 2014 May-Jun;35 Suppl 1:S11-9

Intranasal corticosteroids (INSs) have been effectively used for >40 years for the treatment of seasonal allergic rhinitis (SAR) and perennial AR (PAR). Following the Montreal Protocol, the initial aerosol formulations using chlorofluorocarbon (CFC) propellants were phased out. For the past 20 years, aqueous solutions have been the only available option for INS treatment. In 2012, the U.S. Food and Drug Administration approved two new nonaqueous aerosol AR treatments that use a hydrofluoroalkane (HFA) propellant. In 2012, the first intranasal aqueous combination product was also approved. This article reviews the clinical profiles of HFA beclomethasone dipropionate (BDP) and HFA ciclesonide (CIC) and the aqueous combination intranasal antihistamine (INA)/INS formulation of azelastine hydrochloride/fluticasone propionate (AZE/FP). The medical literature was searched for clinical trials investigating the use of BDP, CIC, and AZE/FP in SAR and PAR. Clinical trials involving aqueous solutions and CFC propellant or HFA propellant delivery were included. Data from prescribing information and published efficacy and safety data were presented as part of the clinical profile for the reviewed agents. AZE/FP has shown efficacy and safety comparable or greater with the current AR treatment options. Although efficacy comparisons of new HFA formulations have not been investigated in head-to-head clinical trials with aqueous formulations, HFA formulations have shown similar efficacy rates. Furthermore, HFA formulations may have some additional benefits, including a preferable sensory profile for some patients. These new formulations will provide additional options for clinicians and patients to better individualize therapy for control of AR.
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http://dx.doi.org/10.2500/aap.2014.35.3756DOI Listing
September 2015

Improving screening and diagnosis of exercise-induced bronchoconstriction: a call to action.

J Allergy Clin Immunol Pract 2014 May-Jun;2(3):275-80.e7. Epub 2014 Feb 4.

BioMedEcon, LLC, Moss Beach, Calif.

This article summarizes the findings of an expert panel of nationally recognized allergists and pulmonologists who met to discuss how to improve detection and diagnosis of exercise-induced bronchoconstriction (EIB), a transient airway narrowing that occurs during and most often after exercise in people with and without underlying asthma. EIB is both commonly underdiagnosed and overdiagnosed. EIB underdiagnosis may result in habitual avoidance of sports and physical activity, chronic deconditioning, weight gain, poor asthma control, low self-esteem, and reduced quality of life. Routine use of a reliable and valid self-administered EIB screening questionnaire by professionals best positioned to screen large numbers of people could substantially improve the detection of EIB. The authors conducted a systematic review of the literature that evaluated the accuracy of EIB screening questionnaires that might be adopted for widespread EIB screening in the general population. Results of this review indicated that no existing EIB screening questionnaire had adequate sensitivity and specificity for this purpose. The authors present a call to action to develop a new EIB screening questionnaire, and discuss the rigorous qualitative and quantitative research necessary to develop and validate such an instrument, including key methodological pitfalls that must be avoided.
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http://dx.doi.org/10.1016/j.jaip.2013.11.001DOI Listing
January 2015

A World Allergy Organization international survey on physical activity as a treatment option for asthma and allergies.

World Allergy Organ J 2014 27;7(1):34. Epub 2014 Nov 27.

Institute of Translational Pharmacology, National research Council, Rome, Italy ; Department of Internal Medicine, Second University of Naples, Naples, Italy.

Background: Physical exercise has been shown to improve asthma symptoms, QoL, exercise capacity, bronchial hyperresponsiveness and lung function and is recommended as a supplementary treatment to pharmacotherapy for asthma. Clinicians are well placed to promote physically active lifestyles, but their role and practice towards promoting physically active lifestyles among patients has not been fully investigated. This study was designed to investigate the knowledge, propensity, attitude and practices of clinicians towards the promotion of physical activity among patients with asthma and allergies.

Methods: Two hundred and eighty clinicians (mean age; 46 ± 13 years; with a clinical experience of practice for 15 ± 7 years) participated in a global survey. The survey comprised a 29-item questionnaire, which gathered information on attitudes of the clinicians towards promoting physical activity, their knowledge and their beliefs regarding evidence for benefits of physical activity as a supplementary treatment in patients with asthma and allergies.

Results: Almost all respondents were aware of the strong evidence in favor of physical activity for the psychological well-being, weight control, decreased risk of diabetes, ischemic heart disease and arterial hypertension. Evidence for reduction in the risk for developing asthma and for better asthma control were reported by 60.0% and 85.4% of participants, respectively. The majority (85.0%) of clinicians strongly agreed that promoting physical activity is important to health care, although 95.5% considered they required more educational training. Although two thirds of them usually recommended exercise to their asthmatic/allergic patients, only 24.0% reported having previous training on the subject of such counseling. Almost all believed that effective counseling about a healthy diet, exercise and weight management would be easier if the clinician himself/herself was physically fit and healthy.

Conclusions: The results of this global survey indicate that clinicians working in the field of allergy and respiratory diseases are well aware of the evidence supporting the benefits of physical activity for asthma and allergic diseases although they need more training in such counseling. Therefore, concerted efforts are needed towards educating clinicians towards promoting physical activity and weight management, as a supplementary treatment for asthma and allergies.
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http://dx.doi.org/10.1186/1939-4551-7-34DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363188PMC
April 2015

Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis.

Ann Allergy Asthma Immunol 2013 Nov 28;111(5):408-414.e1. Epub 2013 Aug 28.

William Storms Allergy Clinic, Colorado Springs, Colorado. Electronic address:

Background: Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.

Objective: To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.

Methods: In this double-blinded, placebo-controlled study, children (6-11 years of age) with seasonal AR were randomized to once-daily treatment with BDP nasal aerosol 80 μg (n = 239) or 160 μg (n = 242) or placebo (n = 234). The primary end point was change from baseline in average morning and evening reflective total nasal symptom score over the 2-week treatment period.

Results: Treatment with BDP nasal aerosol showed significantly greater improvements in average morning and evening reflective total nasal symptom score vs placebo (80 μg, -0.71; 160 μg, -0.76; P < .001 for the 2 comparisons). Similarly, significantly greater improvements in average morning and evening instantaneous total nasal symptom score were seen with BDP nasal aerosol vs placebo (80 μg, -0.63; 160 μg, -0.73; P < .001 for the 2 comparisons). The incidence of adverse events from BDP nasal aerosol was comparable to that from placebo.

Conclusion: BDP nasal aerosol (80 or 160 μg/d) provided significant and clinically meaningful nasal symptom relief and an established overall safety profile similar to that of placebo, suggesting that it is an effective and well-tolerated treatment option for pediatric patients with moderate to severe seasonal AR.

Trial Registration: clinicaltrials.gov Identifier: NCT012073190.
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http://dx.doi.org/10.1016/j.anai.2013.07.033DOI Listing
November 2013

An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction.

Am J Respir Crit Care Med 2013 May;187(9):1016-27

Background: Exercise-induced bronchoconstriction (EIB) describes acute airway narrowing that occurs as a result of exercise. EIB occurs in a substantial proportion of patients with asthma, but may also occur in individuals without known asthma.

Methods: To provide clinicians with practical guidance, a multidisciplinary panel of stakeholders was convened to review the pathogenesis of EIB and to develop evidence-based guidelines for the diagnosis and treatment of EIB. The evidence was appraised and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.

Results: Recommendations for the treatment of EIB were developed. The quality of evidence supporting the recommendations was variable, ranging from low to high. A strong recommendation was made for using a short-acting β(2)-agonist before exercise in all patients with EIB. For patients who continue to have symptoms of EIB despite the administration of a short-acting β(2)-agonist before exercise, strong recommendations were made for a daily inhaled corticosteroid, a daily leukotriene receptor antagonist, or a mast cell stabilizing agent before exercise.

Conclusions: The recommendations in this Guideline reflect the currently available evidence. New clinical research data will necessitate a revision and update in the future.
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http://dx.doi.org/10.1164/rccm.201303-0437STDOI Listing
May 2013

Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review.

Allergy Asthma Proc 2012 Mar-Apr;33(2):172-7

The William Storms Allergy Clinic, Colorado Springs, Colorado 80907, USA.

Controlled clinical trials have shown the recombinant humanized monoclonal anti-IgE antibody omalizumab to improve asthma control and reduce symptom exacerbations in patients with moderate-to-severe allergic asthma who remain clinically unstable despite optimal medical therapy. An objective retrospective review compared clinical experience with the data reported in the controlled studies. Data tracking for 167 patients progressively enrolled between 2003 and 2010 treated with omalizumab included symptoms, forced expiratory volume at 1 second (FEV(1)), systemic steroid bursts, and need for short-acting bronchodilator rescue measured at the start of therapy; 3, 6, and 12 months after starting treatment, and yearly thereafter. Exacerbations were compared for the 12 months before and the 12 months after starting treatment in a subgroup of patients. Asthma control improved with omalizumab over time (up to 6 years) as indicated by fewer symptoms and less need for rescue medication (p < 0.001 for both). FEV(1) remained stable. The number of patients reporting asthma exacerbations requiring urgent care decreased by 49% during the first 12 months of treatment (p ≤ 0.01), and significant reductions in exacerbations were also evident when measured by hospitalizations or systemic corticosteroid bursts (p < 0.001 for both). This is the first long-term pragmatic review of omalizumab. Our clinical experience (up to 6 years in some patients) supports the results of earlier controlled studies, confirming the usefulness of adding omalizumab to the long-term management of patients with difficult-to-treat disease who suffer from persistent symptoms despite optimal therapy with medications.
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http://dx.doi.org/10.2500/aap.2012.33.3527DOI Listing
August 2012

Allergic rhinitis substantially impacts patient quality of life: findings from the Nasal Allergy Survey Assessing Limitations.

J Fam Pract 2012 Feb;61(2 Suppl):S5-10

Allergy and Asthma Medical Group and Research Center, San Diego, CA, USA.

People with allergic rhinitis rate their overall health significantly lower than individuals without nasal allergies. Compared with the general population, more people with AR complain of difficulty getting to sleep, waking up during the night, lack of a good night's sleep, or a combination of these, as a result of their nasal symptoms. More than half of individuals with AR describe their symptoms as impacting daily life a lot or to a moderate degree. More adults with AR report that their health limits them from doing well at work compared with adults without nasal allergies, and their estimated productivity drops by an average of 20% on days when their nasal symptoms are at their worst.
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February 2012

Challenges in the management of exercise-induced asthma.

Authors:
William Storms

Expert Rev Clin Immunol 2009 May;5(3):261-9

The William Storms Allergy Clinic, 1625 Medical Center Point, Suite 190, Colorado Springs, CO 80907, USA.

Exercise and physical activity are common triggers of symptoms in patients with asthma, although some individuals - especially athletes - may have symptoms with exercise alone. Exercise-induced bronchospasm (EIB) describes airway hyper-reactivity that is observed following exercise in a patient who is not otherwise diagnosed with asthma; exercise-induced asthma (EIA) describes airway hyper-reactivity associated with exercise in a patient who has persistent asthma. Specific challenges affecting both the diagnosis and treatment of these conditions are discussed in this review. The past decade has seen substantial advances in our understanding of EIA and EIB, including new guidelines on their management. With appropriate therapy, all patients with exercise-related symptoms should be able to reach their desired level of performance.
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http://dx.doi.org/10.1586/eci.09.10DOI Listing
May 2009

Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis.

Allergy Rhinol (Providence) 2010 Apr;1(2):14

The combination of intranasal antihistamines and intranasal corticosteroids results in superior relief of seasonal allergic rhinitis (SAR) symptoms compared with monotherapy. This study was designed to evaluate the safety and efficacy of olopatadine hydrochloride nasal spray, 0.6% (OLO), administered in combination with fluticasone nasal spray, 50 micrograms (FNS), relative to azelastine nasal spray, 0.1% (AZE), administered in combination with FNS in the treatment of SAR. This was a multicenter, double-blind, randomized, parallel-group comparison of OLO + FNS versus AZE + FNS administered for 14 days to patients ≥12 years of age with histories of SAR. Efficacy assessments recorded by patients in a daily diary included nasal symptom scores. Safety was evaluated based on adverse events (AEs). Pretreatment values for reflective total nasal symptoms scores (rTNSS) were similar for both treatment groups. The mean (SD) 2-week average rTNSS was 4.28 (2.63) for OLO + FNS and 4.15 (2.63) for AZE + FNS; these scores were not statistically different between treatment groups. No significant differences (p > 0.05) between OLO + FNS and AZE + FNS were observed for the average 2-week percent changes from baseline in rTNSS or in the individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing). Compared with baseline, both groups had statistically significant improvement in rTNSS (p < 0.05). No serious AEs were reported in either group during the study period. Overall, 19 AEs were reported in the OLO + FNS group and 29 AEs were reported in the AZE + FNS group. OLO, when administered adjunctively with FNS, is effective, safe, and well-tolerated in patients with SAR.
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http://dx.doi.org/10.2500/aap.2010.31.3326DOI Listing
April 2010

Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis.

Allergy Asthma Proc 2010 Mar-Apr;31(2):132-40. Epub 2010 Mar 18.

North Carolina Clinical Research, Raleigh, North Carolina 27607, USA.

The combination of intranasal antihistamines and intranasal corticosteroids results in superior relief of seasonal allergic rhinitis (SAR) symptoms compared with monotherapy. This study was designed to evaluate the safety and efficacy of olopatadine hydrochloride nasal spray, 0.6% (OLO), administered in combination with fluticasone nasal spray, 50 micrograms (FNS), relative to azelastine nasal spray, 0.1% (AZE), administered in combination with FNS in the treatment of SAR. This was a multicenter, double-blind, randomized, parallel-group comparison of OLO + FNS versus AZE + FNS administered for 14 days to patients > or =12 years of age with histories of SAR. Efficacy assessments recorded by patients in a daily diary included nasal symptom scores. Safety was evaluated based on adverse events (AEs). Pretreatment values for reflective total nasal symptoms scores (rTNSS) were similar for both treatment groups. The mean (SD) 2-week average rTNSS was 4.28 (2.63) for OLO + FNS and 4.15 (2.63) for AZE + FNS; these scores were not statistically different between treatment groups. No significant differences (p > 0.05) between OLO + FNS and AZE + FNS were observed for the average 2-week percent changes from baseline in rTNSS or in the individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing). Compared with baseline, both groups had statistically significant improvement in rTNSS (p < 0.05). No serious AEs were reported in either group during the study period. Overall, 19 AEs were reported in the OLO + FNS group and 29 AEs were reported in the AZE + FNS group. OLO, when administered adjunctively with FNS, is effective, safe, and well-tolerated in patients with SAR.
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http://dx.doi.org/10.2500/aap.2010.31.3326DOI Listing
September 2010

Evaluating approved medications to treat allergic rhinitis in the United States: an evidence-based review of efficacy for nasal symptoms by class.

Ann Allergy Asthma Immunol 2010 Jan;104(1):13-29

Head and Neck Institute, The Cleveland Clinic, Celeveland, OH 44195, USA.

Objective: To evaluate how well the medications currently approved in the United States for allergic rhinitis (AR) treat nasal symptoms when examined according to Food and Drug Administration-indicated uses and dosages.

Data Sources: MEDLINE (1966 onward), EMBASE (1974 onward), and the Cochrane Library (2007) were systematically searched according to the following criteria defined at a roundtable meeting of the authors: randomized controlled trial, at least a 2-week duration, and approved indication and dosage in the United States.

Study Selection: Data from studies that met the inclusion criteria were extracted into evidence tables, which were reviewed twice by the full panel of authors. Individual panel members also were asked to comment on abstracts, articles, and summary tables based on their known expertise. The entire faculty approved the selection of studies included in this review.

Results: Fifty-four randomized, placebo-controlled studies involving more than 14,000 adults and 1,580 children with AR met the criteria for review: 38 studies of seasonal allergic rhinitis (SAR; n = 11,980 adults and 946 children) and 12 studies of perennial allergic rhinitis (PAR; n = 3,800 adults and 366 children). The median percentage changes from baseline for total nasal symptom score for SAR were as follows: nasal antihistamines, -22.2%; oral antihistamines, -23.5%; intranasal steroids (INSs), -40.7%; and placebo, -15.0%. For PAR, the changes were as follows: oral antihistamines, -51.4%; INSs, -37.3%; and placebo, -24.8%. Data for mediator antagonists were limited.

Conclusions: The data, although limited, confirm that INSs produce the greatest improvements in nasal symptoms in patients with SAR. In addition, INSs are effective for PAR, but the data were of variable quality, and oral antihistamines may be equally effective for some patients. The reporting of published data should be standardized to permit better comparisons in future studies.
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http://dx.doi.org/10.1016/j.anai.2009.11.020DOI Listing
January 2010

Comparison of olopatadine 0.6% nasal spray versus fluticasone propionate 50 microg in the treatment of seasonal allergic rhinitis.

Allergy Asthma Proc 2009 May-Jun;30(3):255-62

Institute for Allergy and Asthma, Chevy Chase, Maryland 20817, USA.

The efficacy of nasal antihistamines (NAHs) for allergic rhinitis (AR) is comparable with or better than second-generation oral antihistamines, with faster onset of action and greater effect on congestion. Limited data suggest that NAHs may be equivalent to intranasal corticosteroids at reducing the full range of nasal seasonal AR (SAR) symptoms, including congestion. The efficacy of olopatadine 0.6% nasal spray (2 sprays/nostril b.i.d.) for symptoms of SAR was compared with fluticasone 50 microg nasal spray (2 sprays/nostril q.d.) in a double-blind, randomized, parallel-group, 2-week noninferiority trial. A total of 130 symptomatic patients were randomized to treatment and they recorded nasal and ocular allergy symptom scores b.i.d. (morning and evening) in a diary. Both treatments reduced reflective and instantaneous assessments of nasal and ocular symptoms from baseline throughout the 2-week study period (p < 0.05). The reflective total nasal symptom score (the primary efficacy variable) decreased by an average of -45.4% for patients treated with olopatadine 0.6% and by -47.4% for those treated with fluticasone; statistical significance favoring olopatadine was demonstrated at day 1. No significant between-treatment differences were determined for the average 2-week percent changes from baseline for congestion, runny nose, sneezing, itchy nose, and ocular symptoms, although olopatadine had a faster onset of action for reducing all symptoms. Both treatments were safe and well tolerated. Olopatadine and fluticasone nasal sprays both reduced nasal and ocular SAR symptoms with no significant between-treatment differences except for a faster and greater onset of action with olopatadine.
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http://dx.doi.org/10.2500/aap.2009.30.3232DOI Listing
August 2009

Exercise-induced bronchospasm.

Authors:
William W Storms

Curr Sports Med Rep 2009 Mar-Apr;8(2):45-6

University of Colorado Health Sciences Center, Colorado Springs, CO, USA.

Exercise-induced bronchospasm (EIB) is a relatively common condition that affects both recreational and elite athletes. The latest data suggest that it is an inflammatory process, especially in elite athletes. Proper diagnosis is important to differentiate EIB from other respiratory conditions. Effective treatment usually controls this condition.
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http://dx.doi.org/10.1249/JSR.0b013e31819c7b28DOI Listing
June 2009

Guaifenesin in rhinitis.

Curr Allergy Asthma Rep 2009 Mar;9(2):101-6

The William Storms Allergy Clinic, Colorado Springs, CO 80907, USA.

Mucus in the airways is a complex mixture of water, lipids, glycoproteins, sugars, and electrolytes that serves as a lubricant for the epithelium. The efficient flow of respiratory mucus is a first level of immune defense that requires an appropriate viscosity and elasticity for optimal barrier and ciliary functions. Thickening and drying of airway mucus by respiratory tract infections, allergies, and drugs can impair evacuation. Tenacious, bothersome mucus is an annoying and frequent symptom of rhinitis that is difficult to manage. Common remedies include adequate hydration through fluid intake and nasal washes. The use of mucoactive agents is controversial due to limited data and equivocal efficacy in available studies. Nonetheless, some patients benefit. This review examines the use of guaifenesin (glyceryl guaiacolate) on bothersome nasal mucus associated with rhinitis, including the available published data and clinical experience.
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http://dx.doi.org/10.1007/s11882-009-0015-4DOI Listing
March 2009

Allergic rhinitis-induced nasal congestion: its impact on sleep quality.

Authors:
William Storms

Prim Care Respir J 2008 Mar;17(1):7-18

The Research Center, The William Storms Allergy Clinic, Colorado Springs, CO 80907, USA.

Allergic rhinitis (AR) is an extremely common health problem affecting 20 to 40 million Americans and between 10-25% of the world's population. Patients with AR suffer from both nasal symptoms (congestion, rhinorrhea, itching, and sneezing) and ocular symptoms (itching, redness, and tearing). The negative impact on sleep quality and quantity, and consequently on various aspects of the patient's life, is an under-recognised and under-treated component of AR morbidity. Nasal congestion, which is one of the most bothersome and prevalent symptoms of AR, is thought to be the leading symptom responsible for rhinitis-related sleep problems. In addition to reducing clinical symptoms, pharmacologic therapies for AR that specifically reduce inflammatory cells and mediators - and therefore nasal congestion and other symptoms - should also improve sleep quality and overall quality of life (QOL). Intranasal corticosteroids (INS) are the current mainstay of therapy for AR. Results of a number of clinical trials demonstrate that INS effectively reduce nasal congestion and ocular symptoms, improve sleep quality, and decrease daytime somnolence. Intranasal corticosteroids have also proved to be effective in reducing symptoms of acute rhinosinusitis and nasal polyposis, both of which also negatively impact on sleep quality. Intranasal corticosteroids are considered safe due to their low systemic bioavailability.
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http://dx.doi.org/10.3132/pcrj.2008.00001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6619860PMC
March 2008

Update on montelukast and its role in the treatment of asthma, allergic rhinitis and exercise-induced bronchoconstriction.

Authors:
William Storms

Expert Opin Pharmacother 2007 Sep;8(13):2173-87

The William Storms Allergy Clinic, Colorado Springs, CO 80907, USA.

Montelukast sodium (Singulair, Merck and Co., Inc., Whitehouse Station, NJ) is a selective and orally-active leukotriene receptor antagonist with demonstrated effectiveness for treating allergic asthma and allergic rhinitis in adults and children as young as 12 months of age for allergic asthma and 6 months of age for allergic rhinitis. It was recently approved in the US for prevention of exercise-induced bronchoconstriction in patients who are > or = 15 years of age. This paper updates a prior review of the data on the clinical efficacy of montelukast published in this journal.
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http://dx.doi.org/10.1517/14656566.8.13.2173DOI Listing
September 2007

Therapeutic options for reducing sleep impairment in allergic rhinitis, rhinosinusitis, and nasal polyposis.

Curr Med Res Opin 2007 Sep;23(9):2135-46

The William Storms Allergy Clinic, Colorado Springs, CO, USA.

Background: Patients with inflammatory disorders of the upper airways, such as allergic rhinitis, rhinosinusitis, and nasal polyposis, often have significant sleep disturbances. Poor sleep can lead to fatigue, daytime somnolence, impaired daytime functioning as reflected in lower levels of productivity at work or school, and a reduced quality of life. Although the exact mechanisms by which these inflammatory nasal conditions disturb sleep is not fully understood, congestion appears to be a key factor and is generally the most common and bothersome symptom for patients with these conditions. Successful therapy should improve patients' sleep and well-being without introducing any negative effects on sleep. SCOPE OF LITERATURE SEARCH: Literature searches of Medline, Embase, and abstracts from medical/scientific conferences were conducted for the period of 1995 through mid-2006 for primary and review articles and conference presentations about sleep disturbance related to allergic rhinitis, rhinosinusitis, and nasal polyposis. These searches also sought to identify articles examining how treatments for those diseases improved sleep and, consequently, patients' quality of life. Surveys of the impact of congestion on patients' quality of life and their sleep also were consulted. Clinical studies were selected for discussion if they were randomized, double-blind, and placebo-controlled. Limitations of this review include the absence of any direct comparisons of the effectiveness of different drugs on improving sleep and shortcomings in the statistical methods of the patient surveys.

Findings: Intranasal corticosteroids (INSs) are the most effective medication for reducing congestion in patients with inflammatory nasal conditions. There is a growing amount of evidence that a reduction in congestion with INSs is associated with improved sleep, reduced daytime sleepiness, and enhanced patient quality of life.

Conclusion: Relief of sleep impairment associated with inflammatory disorders of the nose and sinuses can be addressed with INS therapy.
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http://dx.doi.org/10.1185/030079907X219607DOI Listing
September 2007

American Academy of Allergy, Asthma & Immunology Work Group report: exercise-induced asthma.

J Allergy Clin Immunol 2007 Jun 16;119(6):1349-58. Epub 2007 Apr 16.

CompleWare Corporation, Iowa Clinical Research Corporation and Department of Internal Medicine, University of Iowa, Iowa City, Iowa, USA.

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http://dx.doi.org/10.1016/j.jaci.2007.02.041DOI Listing
June 2007

Concerns about intranasal corticosteroids for over-the-counter use: position statement of the Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology.

Ann Allergy Asthma Immunol 2006 Apr;96(4):514-25

Department of Medicine, UMDNJ-New Jersey Medical School, Newark, USA.

The Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology was charged with formulating a position paper regarding the potential release of intranasal corticosteroids for over-the-counter use. We took the position that safety issues regarding this proposal would be our sole concern. We reviewed the literature to evaluate the frequency and severity of potential adverse events related to the administration of intranasal corticosteroids. We limited this review to 5 areas: (1) effects on growth, (2) ocular effects, (3) effects on bone, (4) effects on the hypothalamic-pituitary-adrenal axis, and (5) local adverse effects. After review of the available data, we concluded that intranasal corticosteroids should remain prescription-only drugs. Patients receiving an intranasal corticosteroid should be instructed in its use and that use should be monitored by a physician or an appropriately trained medical provider (eg, nurse practitioner or physician assistant) under the direct supervision of a physician. This conclusion was reached based on the evidence that corticosteroids administered by any route, including the intranasal route, have the potential to cause adverse effects in all the areas noted herein. Our conclusion was strengthened by the fact that these adverse effects can be insidious and therefore not evident for many years; there is the potential for overuse; patients could also have access to other forms of topically administered corticosteroids, thus increasing their total dose; and individuals vary in their susceptibility to corticosteroid-induced adverse effects. We were also influenced to take this position knowing that generally reassuring data regarding the use of respiratory tract-administered corticosteroids are based on mean data and that all such studies have shown outliers in whom adverse effects were evident. Thus, as stated, we recommend that intranasal corticosteroids remain prescription-only drugs.
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http://dx.doi.org/10.1016/S1081-1206(10)63545-4DOI Listing
April 2006

Treatment of patients with osteoarthritis with rofecoxib compared with nabumetone.

J Clin Rheumatol 2006 Feb;12(1):17-25

University of Nebraska Medical Center, Omaha, Nebraska, USA.

Background: Rofecoxib and nabumetone were developed to provide gastrointestinal benefits over traditional nonsteroidal antiinflammatory drugs (NSAIDs). However, there is limited comparative information relating to these 2 drugs.

Objective: The objective of this study was to compare rofecoxib and nabumetone, at their lower, recommended doses, in patients with osteoarthritis (OA).

Methods: Nine hundred seventy-eight patients with knee OA and a positive history of NSAID response were randomized to 12.5 mg rofecoxib per day (N=390), nabumetone 500 mg twice a day (N=392), or placebo (N=196) for 6 weeks. The primary efficacy end point was percent of patients with a "good" or "excellent" Patient Global Assessment of Response to Therapy (PGART) at week 6; PGART was also evaluated over days 1 to 6. Additional end points included investigator assessment of response, pain walking over 6 days and 6 weeks, joint tenderness, discontinuation as a result of lack of efficacy, and quality of life. Adverse experiences (AEs) were collected.

Results: Significantly more rofecoxib (50.4%) than nabumetone (43.3%, P=0.043) or placebo (29.5%, P<0.001) patients had a good or excellent PGART at week 6. Median time to a good or excellent PGART was significantly shorter with rofecoxib (52 hours) than nabumetone (100 hours, P=0.001) or placebo (>124 hours, P<0.001). Results for rofecoxib and nabumetone were similar in all additional end points except pain in walking over 6 days and 6 weeks, in both of which the rofecoxib treatment group demonstrated better results. There were significantly (P<0.050) more overall and serious AEs and discontinuations resulting from AEs with rofecoxib than nabumetone. Five rofecoxib and one nabumetone patients had confirmed thrombotic cardiovascular events (P=0.123). Information on thrombotic cardiovascular events from this study was included in a published, prespecified pooled analysis and is included here for completeness.

Conclusions: At their recommended starting doses for OA, both agents were more effective than placebo. Rofecoxib at a dosage of 12.5 mg demonstrated significantly better efficacy in PGART than 1000 mg nabumetone in these patients known to be NSAID responders. Significantly more AEs occurred with rofecoxib than nabumetone. Considering these data and other recent safety information regarding cyclooxygenase-2 selective and nonselective NSAIDS, physicians must make risk/benefit assessments for each individual patient when considering the use of these agents, as recommended by the U.S. Food and Drug Administration.
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http://dx.doi.org/10.1097/01.rhu.0000200384.79405.33DOI Listing
February 2006

Effects of adjuvant therapy with 0.1% olopatadine hydrochloride ophthalmic solution on quality of life in patients with allergic rhinitis using systemic or nasal therapy.

Ann Allergy Asthma Immunol 2005 Oct;95(4):361-71

Southern California Research, Mission Viejo, California, USA.

Background: Allergic rhinoconjunctivitis patients are often treated with nasal or systemic allergy therapy, forgoing therapy for ocular symptoms. This treatment regimen leaves important aspects of the allergic reaction untreated and affects quality of life (QoL). The Rhinoconjunctivitis Quality of Life Questionnaire and the Allergic Conjunctivitis Quality of Life Questionnaire quantify separate aspects of QoL.

Objective: To determine the benefit gained in QoL, measured by these questionnaires, when antiallergy eyedrops (olopatadine) were added to patients' preexisting regimens of nasal or systemic allergic rhinitis treatment.

Methods: This was a 4-week prospective, multicenter, open-label, crossover, environmental QoL study. Visit 1 randomized patients to treatment group A or B and included baseline examinations and questionnaires. Group A instilled olopatadine twice daily and concomitantly with previously prescribed nasal or systemic antiallergy medication for 2 weeks. Group B received no ocular therapy and used only previously prescribed antiallergy medication for 2 weeks. Treatment group crossover occurred at visit 2. Patients again completed the questionnaires at visits 2 and 3.

Results: Two hundred patients completed the study, 97 in group A and 103 in group B. Groups A and B experienced ocular allergic symptoms for 3.88 and 3.96 days, respectively, during the week before baseline. At visits 2 and 3, questionnaire scores were significantly improved for each group when olopatadine was added compared with the nontreatment periods. By visit 2, olopatadine improved QoL by 49% compared with 5% in the nontreated group (P < .001).

Conclusions: In this study, 90.5% of patients with allergic rhinitis treated nasally or systemically also had ocular allergic symptoms. Adding olopatadine to these patients' medication regimens significantly improved ocular allergic symptoms and overall QoL.
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http://dx.doi.org/10.1016/S1081-1206(10)61155-6DOI Listing
October 2005

Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis.

Clin Ther 2005 May;27(5):543-53

Allergy Research Foundation, Inc., Los Angeles, California 90025, USA.

Background: Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR).

Objective: The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR.

Methods: This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged > or =18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14.

Results: Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated.

Conclusion: In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.
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http://dx.doi.org/10.1016/j.clinthera.2005.04.012DOI Listing
May 2005

Cromolyn sodium: fitting an old friend into current asthma treatment.

J Asthma 2005 Mar;42(2):79-89

University of Colorado Health Sciences Center, Colorado Springs, Colorado 80907, USA.

Cromolyn sodium (Intal) has been available in the United States to treat asthma for more than 30 years. Its clinical efficacy in patients with mild or moderate persistent asthma is well documented, and its extensive clinical record of safety remains unique among antiasthma medications. The history of cromolyn sodium complements the science behind current understanding of asthma pathophysiology. Cromolyn sodium was the first nonsteroid, antiasthma drug that blocked chemical mediator release at the cellular level. However, the younger generation of health care providers may not be familiar with the medication due to the plethora of antiasthma agents that have recently become available. This review reexamines the role of cromolyn sodium (now available as an HFA aerosol) in the treatment of asthma.
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March 2005