Phase 3 Completed N=416 Randomized Quadruple-blind Treatment

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00624286 ↗

Enrolled (actual)

416

Serious AEs

2.9%

Results posted

Aug 2011

Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) — 1.48; 1.35 Liters

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	1.48; 1.35	—
SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2	1.47; 1.38	—

Eligibility Criteria

Inclusion Criteria

Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus
20 pack-year smoking history
Signed informed consent
Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria include:

History of asthma
Prior exposure to indacaterol
Active cancer or history of cancer
Patients with concomitant pulmonary disease
Patients with diabetes Type I or uncontrolled diabetes Type II
Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00624286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.