12-week Efficacy of Indacaterol

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Indacaterol 75 μg; Drug: Placebo to indacaterol

• Registration Number: NCT01072448
• Lead Sponsor: Novartis

Brief Summary

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-07
• Results First Submitted: 2011-07-22
• Results First Submitted QC: 2011-07-22
• Last Update Submitted: 2011-07-22
• Results First Posted: 2011-08-19
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indacaterol 75 μg	Indacaterol 75 μg	Patients inhaled indacaterol 75 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.
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.

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 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Name	Time	Method
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)	End of the study (Week 12, Day 84)	An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Trial Locations

Locations (3)

Novartis Investigative site; 🇺🇸 Greer, South Carolina, United States

Novartis Investigator Site; 🇺🇸 Tacoma, Washington, United States

Novartis Investigative Site; 🇺🇸 Newport News, Virginia, United States