Long-Term Maintenance Bronchodilation With Indacaterol/Glycopyrrolate Versus Indacaterol in Moderate-to-Severe COPD Patients: The FLIGHT 3 Study
| Autor: | Agnes Annette Schubert-Tennigkeit, Gary T. Ferguson, Angel Fowler Taylor, Qian Wang, Donald Banerji, Chau Thach, Francesco Patalano |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Pulmonary and Respiratory Medicine
COPD business.industry biochemical phenomena metabolism and nutrition medicine.disease Discontinuation Clinical trial 03 medical and health sciences 0302 clinical medicine 030228 respiratory system Tolerability Anesthesia medicine Indacaterol 030212 general & internal medicine Adverse effect business Mace Glycopyrrolate medicine.drug Original Research |
| Popis: | Background: The objective of the FLIGHT3 study was to evaluate the long-term safety and efficacy of indacaterol/glycopyrrolate* (IND/GLY) versus an active comparator, IND, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) over 52 weeks. Method: FLIGHT3 was a multicenter, randomized, double-blind, parallel-group, 52-week study. Patients were randomized (1:1:1) to IND/GLY (27.5/15.6 or 27.5/31.2 µg twice daily [b.i.d.]) or IND (75 µg once daily [o.d.]), delivered via the Neohaler® device. The primary objective was to evaluate the long-term safety and tolerability of IND/GLY versus IND in terms of adverse event (AE)-reporting rates in patients with moderate-to-severe COPD over 52 weeks. The secondary objective was to evaluate the long-term efficacy of IND/GLY versus IND in terms of pre-dose trough forced expiratory volume in 1 second (FEV1) and post-dose 1-h FEV1 over 52 weeks. Results: A total of 85.2% patients completed the study treatment. The overall incidence of AEs (and SAEs) was similar between treatments. Major adverse cardiovascular events (MACE) and/or cardiovascular (CV) events were comparable between treatment groups. The rate of discontinuation of the study treatment due to AEs was lower for IND/GLY than IND. Improvements in pre-dose trough FEV1 and post-dose 1-h FEV1 were consistently superior with IND/GLY than with IND over 52 weeks, demonstrating long-term maintenance of lung function. Conclusions: IND/GLY demonstrated a favorable long-term safety and tolerability profile and provided effective bronchodilation, with maintenance of lung function over 52 weeks in patients with moderate-to-severe COPD. These data support the safety and efficacy of IND/GLY as a treatment option for COPD. Trial registration: ClinTrials.gov identifier NCT01682863 *Glycopyrrolate 15.6 µg (excluding the bromide salt) is equivalent to 12.5 µg glycopyrronium. |
| Databáze: | OpenAIRE |
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