Publications by authors named "Annette Sperl"

11 Publications

  • Page 1 of 1

An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children.

Multidiscip Respir Med 2020 Jan 3;15(1):511. Epub 2020 Mar 3.

Global Medical Lead CHC, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Ambroxol (2-amino-3,5-dibromo-N-[trans-4-hydroxycyclohexyl]benzylamine), an over-the-counter product, is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978. This review aims to provide an overview of the clinical evidence available on the use of ambroxol in children with acute and chronic respiratory diseases. Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies. Although conducted prior to the introduction of Good Clinical Practice (GCP), these studies, representing almost 1,300 pediatric patients, report strong clinical outcomes following the use of ambroxol in pediatric patients. Furthermore, efficacy findings were consistent irrespective of age, including for patients as young as 1 month old. Additionally, the majority of studies found ambroxol to be well tolerated in children. Taken together, the clinical evidence for ambroxol shows treatment effects that offer significant benefits to pediatric patients for its licensed use as a secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport. The findings from this review indicate that ambroxol, for its intended over-the-counter indications, is both efficacious and well tolerated in children and that the favorable benefit/risk profile of ambroxol reported in adults extends to the pediatric population, starting from early infancy, with acute and chronic respiratory diseases.
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http://dx.doi.org/10.4081/mrm.2020.511DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137760PMC
January 2020

ARIA guideline 2019: treatment of allergic rhinitis in the German health system.

Allergol Select 2019 30;3(1):22-50. Epub 2019 Dec 30.

Department of Dermatology, University Medical Center Mainz,Mainz, Germany.

Background: The number of patients affected by allergies is increasing worldwide. The resulting allergic diseases are leading to significant costs for health care and social systems. Integrated care pathways are needed to enable comprehensive care within the national health systems. The ARIA (Allergic Rhinitis and its Impact on Asthma) initiative develops internationally applicable guidelines for allergic respiratory diseases.

Methods: ARIA serves to improve the care of patients with allergies and chronic respiratory diseases. In collaboration with other international initiatives, national associations and patient organizations in the field of allergies and respiratory diseases, real-life integrated care pathways have been developed for a digitally assisted, integrative, individualized treatment of allergic rhinitis (AR) with comorbid asthma. In the present work, these integrated care pathways have been adapted to the German situation and health system.

Results: The present ICP (integrated care pathway) guideline covers key areas of the care of AR patients with and without asthma. It includes the views of patients and other healthcare providers.

Discussion: A comprehensive ICP guideline can reflect real-life care better than traditional guideline models.
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http://dx.doi.org/10.5414/ALX02120EDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066682PMC
December 2019

[Therapy of Allergies and Allergy Immunotherapy in Children].

Laryngorhinootologie 2020 01 14;99(1):56-66. Epub 2020 Jan 14.

Adequate diagnostical workup for respiratory allergies and consequent therapy in children determine the individual course of disease. Therapy consists first of symptomatic treatment and includes in the next step the important option of allergy immunotherapy (AIT) as a causative treatment of disease. Children are an important target group for AIT, since AIT offers a proven longterm effect including secondary preventive properties with not only transiently reduced symptoms but moreover longstanding and beneficial disease modification.New strategies with AIT as primary and secondary preventive interventions are being evaluated with the aim to reduce clinical appearance and the amount and extent of sensitizations to allergens in high-risk children. Until implementation of such potentially preventive strategies the currently more attractive early intervention is the early adoption of AIT within the first 12 to 24 months of onset of symptoms as a first-line treatment of allergic rhinitis.Simplified treatment protocols can improve the willingness to perform an AIT and the adherence and compliance of children and their parents. The overall goal is to make AIT as the most important treatment modality available to more affected children.
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http://dx.doi.org/10.1055/a-0899-1202DOI Listing
January 2020

Current therapeutical strategies for allergic rhinitis.

Expert Opin Pharmacother 2019 01 15;20(1):83-89. Epub 2018 Nov 15.

d Department of General Otorhinolaryngology , Medical University of Graz , Graz , Austria.

Introduction: Allergic rhinitis is a common condition with increasing prevalence and is associated with several comorbid disorders such as bronchial asthma and atopic dermatitis. If allergen avoidance is not possible, allergen-specific immunotherapy is the only causal treatment option.

Areas Covered: This review focuses on current treatments and the future outlook for allergic rhinitis. Pharmacotherapy includes mast cell stabilizers, antihistamines, glucocorticosteroids (GCSs), leukotriene receptor antagonists, and nasal decongestants. Nasal GCSs are currently regarded as the most effective treatment and are considered first-line therapy together with non-sedating antihistamines. The new formulation MP29-02 combines the nasal GCS fluticasone propionate with azelastine in one single spray and has achieved greater improvements than those under monotherapy with modern GCSs or antihistamines. Furthermore, this review discusses allergen immunotherapy alone and in combination with modern monoclonal antibodies.

Expert Opinion: Despite the variety of medications for allergic rhinitis, ranging from general symptomatic agents like GCSs or decongestants, to more specific ones like histamine receptor or leukotriene blockers, to causal therapy like immunotherapy, many patients still experience treatment failures or unsatisfactory results. The ultimate goal may be to endotype every downstream pathway separately in order to offer patients individualized, targeted therapy with specific antibodies against the respective pathway.
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http://dx.doi.org/10.1080/14656566.2018.1543401DOI Listing
January 2019

Safety of ambroxol in the treatment of airway diseases in adult patients.

Expert Opin Drug Saf 2018 Dec 22;17(12):1211-1224. Epub 2018 Nov 22.

c Global Medical Affairs , Sanofi Aventis Deutschland GmbH , Frankfurt am Main , Germany.

Introduction: Ambroxol is a widely used secretolytic and mucoactive over-the-counter agent primarily used to treat respiratory diseases associated with viscid mucus. Following post-marketing reports of hypersensitivity reactions and severe cutaneous adverse reactions (SCARs) possibly linked to ambroxol, the European Union's Pharmacovigilance Risk Assessment Committee (PRAC) initiated in April 2014 a review of the safety of ambroxol in all its registered indications, which was finalized in 2016. Areas covered: Here, we evaluate the clinical safety of ambroxol and provide an expert opinion on the benefit-risk balance of ambroxol in the treatment of adult patients with bronchopulmonary diseases. The evidence for this review is derived from clinical trials of ambroxol that were provided to the PRAC by the marketing authorization holders of ambroxol-containing medicines. Expert opinion: Clinical experience accumulated from randomized clinical trials and observational studies suggests that ambroxol is a safe and well-tolerated treatment of bronchopulmonary diseases, with a well-balanced and favorable benefit-risk profile. All reported adverse events were mild and self-limiting, and the risk of SCARs with ambroxol is low. Further investigations could address the safety and efficacy of ambroxol in pediatric lung diseases and in additional therapeutic indications, such as biofilm-dependent airway disease and lysosomal storage disorders.
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http://dx.doi.org/10.1080/14740338.2018.1533954DOI Listing
December 2018

[Anaphylaxis - Causes, therapy and prevention].

MMW Fortschr Med 2017 Nov;159(Suppl 3):76-84

, München, Deutschland.

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http://dx.doi.org/10.1007/s15006-017-9600-yDOI Listing
November 2017

Olfaction in patients with allergic rhinitis: an indicator of successful MP-AzeFlu therapy.

Int Forum Allergy Rhinol 2017 03 26;7(3):287-292. Epub 2016 Nov 26.

Interdisciplinary Centre "Smell & Taste," Department of Otorhinolaryngology, Technische Universität Dresden, Dresden, Germany.

Background: The purpose of this study was to investigate the effect of MP-AzeFlu on olfaction and the interaction between severity of allergic rhinitis and olfactory improvement after therapy.

Methods: A prospective, multicenter, observational study was performed on 47 patients with persistent allergic rhinitis. Duration and severity of allergic rhinitis was diagnosed and classified using the modified Allergic Rhinitis and its Impact on Asthma (ARIA) criteria and the proof of allergen sensitization from positive skin-prick tests, specific immonoglobulin E (IgE) in serum, and nasal provocation response. Patients were treated with MP-AzeFlu (1 spray/nostril twice daily) over 3 months. Olfactory function was assessed at baseline and at 1 and 3 months of therapy using the "Sniffin' Sticks" test. In addition, a nasal symptom score was recorded on a visual analog scale (VAS) at each given time-point.

Results: MP-AzeFlu was found to be associated with a significant improvement in TDI score, from 23.7 at baseline to 34.2 at 1 month (p < 0.001) and 37.1 at 3 months (p < 0.001) of treatment. Furthermore, a highly significant improvement of symptoms over time (p < 0.001; VAS at baseline: 84.3; 1 month: 32.4; 3 months: 26.2) could be demonstrated. Most importantly, there was a highly significant interaction between the severity of allergic rhinitis and olfactory function (p < 0.001) and VAS (p < 0.001).

Conclusion: MP-AzeFlu is associated with olfactory improvement in persistent allergic rhinitis patients. Further, the modified ARIA severity classification is an indicator of patients' olfactory function. Moreover, assessment of olfaction seems to be a reliable indicator of the clinical success of antiallergic/antiinflammatory therapy.
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http://dx.doi.org/10.1002/alr.21877DOI Listing
March 2017

[Therapy of allergic rhinitis].

Med Monatsschr Pharm 2016 Mar;39(3):105-11

If the avoidance of the provoking allergen is insufficient or not possible, medical treatment can be tried. Therapeutics of the first choice for the treatment of the seasonal and persistent allergic rhinitis are antihistamines and topical glucocorticoids. Chromones are less effective so they should only be used for adults with a special indication, for example during pregnancy. Beside the avoidance of the allergen the immunotherapy is the only causal treatment of allergic diseases.
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March 2016

[Diagnostic methods of allergic rhinitis].

Med Monatsschr Pharm 2016 Mar;39(3):100-4

The diagnosis of allergic rhinitis is based on a typical history with allergic symptoms and the results of diagnostic tests which are directed in vivo and in vitro on the detection of free or cell bound IgE antibodies. However, the detection of specific IgE antibodies does not imply the presence of clinical relevance, yet merely indicates the presence of a specific sensitization.
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March 2016

[Pharmacy based sore throat therapy according to current guidelines].

Med Monatsschr Pharm 2015 Dec;38(12):503-8

Sore throat should be treated symptomatically in self-medication. Due to the mainly viral origin of the disease and the lack of efficiency data, local antibiotics or antiseptics should not be recommended. systemic analgesics as acetylsalicylic acid, acetaminophen, flurbiprofen, or ibuprofen are valid treatment options. Clinical trials suggest that ibuprofen shows the best benefit-risk profile. Flurbiprofen could show efficiency in current trials but head-to-head data with other analgesics (e.g. ibuprofen) are missing. There are currently three local anesthetics available with confirmed efficiency in clinical trials: lidocain (8mg), benzocaine (8 mg) and ambroxol (20 mg). They can be recommended in the first-line treatment. Among these ambroxol has the best documented benefit-risk profile in the therapy of acute sore In the light of evidence based medicine, patients asking for local therapeutics can be treated with local anesthetics.
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December 2015

A prospective study comparing the efficacy and safety of two sublingual birch allergen preparations.

Clin Transl Allergy 2014 23;4:23. Epub 2014 Jul 23.

Center for Rhinology and Allergology Wiesbaden, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Wiesbaden, Germany.

Background: SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula verrucosa pollen extract for the treatment of allergic rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order to compare the clinical efficacy and safety of both products, the present study was designed to investigate efficacy of treatment with SUB-B compared to Stal-B by means of reduction in allergy symptoms assessed by a titrated nasal provocation test (TNPT) in subjects suffering from IgE mediated allergy complaints triggered by birch pollen.

Methods: A prospective, randomized, open, blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or Stal-B (initial phase 10 I.R./ml and maintenance phase 300 I.R./ml) for 16-20 weeks at maintenance dose. The primary efficacy outcome was defined by the difference in change of the TNPT-threshold dose between the two treatment groups at baseline and after completion of treatment. Secondary outcomes included determination of birch pollen specific IgE and IgG levels, safety lab and ECG. During the first 30 days of treatment, subjects were requested to fill out a diary concerning compliance with study medication, occurrence of AEs and the use of concomitant medication.

Results: Analysis of the primary efficacy parameter showed that the percentage of subjects showing a beneficial treatment effect was similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the intention to treat population. Evaluation of the immunologic response, showed that treatment with SUB-B and Stal-B induced similar increases (approximately 2 times) in IgE, IgG and IgG4 specific for Bet v 1. In total, 143 related adverse events (AEs) were reported. The majority of the AEs was of mild intensity. The same pattern of AEs was observed for both products. No clinically relevant changes in other safety parameters, such as safety laboratory parameters, vital signs, physical examination and ECGs were observed.

Conclusion: Taken together, treatment with both products was effective by means of reduction in allergic symptoms during a TNPT. In addition, safety analysis revealed a good tolerability of both SLIT extracts.
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http://dx.doi.org/10.1186/2045-7022-4-23DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4122029PMC
August 2014