drugset / Trial / NCT00624286
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2008-02
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Met primary endpoint
paper Trough FEV1 (LSM +/- SEM) at Week 12 was 1.48 +/- 0.018 L for indacaterol and 1.35 +/- 0.019 L for placebo PMID 20211002 ↗
paper a clinically relevant difference of 130 +/- 24 mL (p < 0.001). PMID 20211002 ↗
Publications
- Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
- Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.
- Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |