Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

Phase 3

Completed

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

• Registration Number: NCT01068600
• 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: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Primary Completion: 2010-06
• 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: 318

Inclusion Criteria

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to indacaterol	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 75 µg	Indacaterol	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Primary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment	after 12 weeks	Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

Secondary Outcome Measures

Name	Time	Method
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment	after 12 weeks	TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

Trial Locations

Locations (3)

Novartis Investigator Site; 🇺🇸 McKinney, Texas, United States

Novartis Investigative Site; 🇺🇸 Richmond, Virginia, United States

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