Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Salmeterol Xinafoate

Criteria

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

• Smoking history of at least 20 pack years

• Post-bronchodilator Forced Expiratory Volume in 1 second (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.