Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Summary

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

• Male and female patients age 40 years or more

• Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008

• Smoking history of at least 10 pack-years

• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value

• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7

• Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3

Exclusion Criteria:

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit

• Patients who have had a respiratory tract infection within 4 weeks prior to the first visit

• Patients with concomitant pulmonary disease

• 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 co-morbid conditions

• Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years

• Patients with eczema, known high IgE levels or a known positive skin prick test

• Patients participating in the active phase of a pulmonary rehabilitation programme

• Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines

• Patients with a history of alpha-1 anti-trypsin deficiency

• Patients on long term oxygen therapy (>15hr per day)

• Other protocol-defined inclusion/exclusion criteria may apply