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

Phase 3

Completed

Brief 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).

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo to indacaterol	Placebo to indacaterol	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 150 μg	Indacaterol 150 μg	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Primary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2	24 hours post-dose on Day 2	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.