Tiotropium Respimat Add-on Is Efficacious in Symptomatic Asthma, Independent of T2 Phenotype
| Autor: | Huib A. M. Kerstjens, Eric D. Bateman, Michael Engel, Petra Moroni-Zentgraf, Hendrik Schmidt, J. Christian Virchow, Thomas B. Casale, Mark Vandewalker |
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| Přispěvatelé: | Groningen Research Institute for Asthma and COPD (GRIAC) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Respimat Exacerbation AIRWAY law.invention 0302 clinical medicine Randomized controlled trial Maintenance therapy law Adrenal Cortex Hormones Immunology and Allergy 030212 general & internal medicine PREDICTORS Salmeterol Xinafoate Drug Synergism Middle Aged RANDOMIZED CONTROLLED-TRIAL Bronchodilator Agents LUNG-FUNCTION Drug Combinations Phenotype Asthma Control Questionnaire Anesthesia Cytokines Female Salmeterol CLINICAL-TRIALS medicine.drug Adult medicine.medical_specialty Adolescent Placebo 03 medical and health sciences Young Adult Th2 Cells SALMETEROL INFLAMMATION Internal medicine Administration Inhalation medicine Journal Article Humans Albuterol Ipratropium Drug Combination Adrenergic beta-2 Receptor Agonists Asthma Aged business.industry medicine.disease respiratory tract diseases MODEL EXACERBATIONS 030228 respiratory system MODERATE business |
| Zdroj: | Journal of Allergy and Clinical Immunology: In Practice, 6(3), 923-935. American Academy of Allergy, Asthma and Immunology |
| ISSN: | 2213-2201 2213-2198 |
| Popis: | BACKGROUND: Adding tiotropium to existing inhaled corticosteroid (ICS) maintenance therapy with or without a long-acting β2-agonist (LABA) has been shown to be beneficial in patients with symptomatic asthma.OBJECTIVE: To assess whether responses to tiotropium Respimat add-on therapy were influenced by patients' T2 status.METHODS: In this exploratory study, data from 4 phase III trials were analyzed: once-daily tiotropium 5 μg or placebo as add-on to ICS + LABA (PrimoTinA-asthma; 2 replicate trials; NCT00772538/NCT00776984; n = 912); once-daily tiotropium 5 μg or 2.5 μg, twice-daily salmeterol 50 μg, or placebo as add-on to ICS (MezzoTinA-asthma; 2 replicate trials; NCT01172808/NCT01172821; n = 2100). The prespecified efficacy outcomes of these studies have been reported previously. Here, further exploratory subgroup analyses were performed to study whether these coprimary end points were influenced by serum IgE levels, blood eosinophil counts, and clinician judgment of allergic asthma. In addition, for the continuous parameters, namely, IgE and blood eosinophils, their influence on the treatment effect was modeled over the whole range of values.RESULTS: Tiotropium was efficacious in improving peak FEV1 within 3 hours postdose and trough FEV1, independent of T2 status. Tiotropium significantly reduced the risk of severe asthma exacerbations and asthma worsening, independent of T2 phenotype; Cox regression modeling supported a beneficial effect of tiotropium on exacerbations, independent of IgE levels or eosinophil counts. Numerical improvements in the 7-question Asthma Control Questionnaire (ACQ-7) responder rate with tiotropium versus placebo were observed in T2high and T2low patients; logistic regression modeling provided further evidence for improvement in ACQ-7 responder rates with tiotropium, independent of IgE levels or eosinophil counts.CONCLUSIONS: The results of our exploratory analyses suggest that the improvements seen with tiotropium Respimat as add-on to ICS ± LABA in patients with symptomatic asthma on lung function, exacerbation risk, and symptom control are independent of T2 phenotype. |
| Databáze: | OpenAIRE |
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