A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

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

Details

• Lead Sponsor: Novartis
• Treatments: Bromides; Glycopyrrolate

Criteria

Inclusion Criteria:

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

• Smoking history of at least 10 pack-years

• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value

• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria:

1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1

2. Patients with concomitant pulmonary disease

3. Patients with a history of asthma

4. Any patient with lung cancer or a history of lung cancer

5. Patients with a history of certain cardiovascular comorbid conditions

6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

7. Patients in the active phase of a supervised pulmonary rehabilitation program

8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply