Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

• Status: Withdrawn
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.

• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7

• Patients with no record of receipt of maintenance medication for COPD.

• Patients with a mMRC dyspnea score ≥1 at Visit 2.

• Current or ex-smokers who have a smoking history of at least 10 pack years.

Exclusion Criteria:

• Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.

• Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.

• Patients who have had a respiratory tract infection.

• Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.

• Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.

• Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.

• Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis

• Other protocol-defined inclusion/exclusion criteria may apply.