Official Title: “A 26-Week Treatment, Multi-Center, Randomized, Double-Blind, Double- Dummy, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control”

This study will evaluate the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Indacaterol
• Drug: placebo
• Drug: Salmeterol

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
• Active Comparator: 3

Primary Measures

• Forced expiratory volume in 1 second (FEV₁) after 12 weeks of treatment measured 24 hours after having taken medication

Secondary Measures

• Effect of indacaterol on percentage of "days of poor control" of COPD over 26 weeks
• Total score of St.George's Respiratory Questionnaire
• Health related quality of life assessments
• Time to first COPD exacerbation and COPD exacerbation rate
• Lung function tests (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC])
• trough FEV1
• standardized area under the curve (AUC) for FEV1

Inclusion Criteria:

• Clinical diagnosis of moderate to severe COPD as per GOLD 2006 Guidelines (mandatory) and including:
• Smoking history of at least 20 pack years
• Post-bronchodilator FEV1 < 80% predicted and >or= 30% of predicted normal value
• Post-bronchodilator FEV1/FVC < 70%
• ("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

• Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
• Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
• Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
• Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
• Concomitant pulmonary disease
• Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
• History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
• Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
• History of reactions to sympathomimetic amines or inhaled medication
• Inability to use the dry powder devices or perform spirometry
• Irregular day/night, wake/sleep cycles, e.g. shift workers
• Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
• Patients unable or unwilling to complete a patient diary
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma AG Study Chair Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567996

Study ID Number: CQAB149B2336

ClinicalTrials.gov Identifier: NCT00567996

Health Authority: Brazil: Ministry of Health