To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Indacaterol

• Registration Number: NCT01272362
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 625

Inclusion Criteria

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

  1. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
  2. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

• Smoking history of at least 10 pack-years

Exclusion Criteria

• Patients who have had a COPD exacerbation in the 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 4 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indacaterol	Indacaterol	-

Primary Outcome Measures

Name	Time	Method
Coefficient of correlation between FEV1 and reversibility	After 1 month	Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening

Secondary Outcome Measures

Name	Time	Method
Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility	5 months	Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Villefranche sur Saone, France