A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting β2-adrenergic agonist, in asthma; a Phase II, randomized study
| Autor: | Sandrine Ruiz, Dave Singh, Gonzalo de Miquel, Beatriz Seoane, Eric Massana, Anna Ribera, Carol Astbury, Helena Pujol |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male medicine.drug_class Abediterol Vital Capacity LABA Quinolones chemistry.chemical_compound Double-Blind Method Bronchodilator Forced Expiratory Volume Administration Inhalation medicine Humans Adrenergic beta-2 Receptor Agonists Asthma Cross-Over Studies Inhalation business.industry Dose-finding Middle Aged Dose-ranging study medicine.disease Crossover study respiratory tract diseases Chronic respiratory disease Bronchodilator Agents Treatment Outcome chemistry Anesthesia Salbutamol Bronchodilation Female business hormones hormone substitutes and hormone antagonists medicine.drug Research Article |
| Zdroj: | BMC Pulmonary Medicine |
| ISSN: | 1471-2466 |
| Popis: | Background Long-acting β2-adrenergic agonists (LABAs) are recommended in combination with inhaled corticosteroids (ICSs) for asthma management. Abediterol is a novel, selective, potent, once-daily LABA in development for treatment of asthma and chronic obstructive pulmonary disease. This study aimed to determine abediterol doses with similar peak bronchodilatory effect to salbutamol 400 μg, and duration of action compatible with once-daily dosing in patients with persistent, stable asthma. Methods This was a Phase II, randomized, double-blind, double-dummy, crossover, placebo-controlled, dose-ranging study (ClinicalTrials.gov NCT01425801) in 62 patients with mild-to-moderate asthma who were also receiving an ICS. Patients received single doses of abediterol 0.313, 0.625, 1.25, or 2.5 μg, salbutamol 400 μg, or placebo in the morning. Spirometry was performed up to 36 h post-dose; safety and tolerability were assessed throughout the study. The primary endpoint was change from baseline in peak forced expiratory volume in 1 s (FEV1). Additional endpoints included trough FEV1, normalized area under the FEV1 curve (FEV1 AUC) up to 24 h post-dose, and peak and trough forced vital capacity (FVC). Results Abediterol produced dose-dependent improvements in peak FEV1 from baseline compared with placebo, from 0.274 (95% CI 0.221, 0.327) to 0.405 L (95% CI 0.353, 0.458) for abediterol 0.313 to 2.5 μg, respectively (p |
| Databáze: | OpenAIRE |
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