Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Glycopyrrolate; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline

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

• Qualifying FEV1 at Visit 2 (day -7)

Exclusion Criteria:

• Patients with a history of asthma or a history of high blood eosinophil count (>600/mm³)

• Patients with concomitant pulmonary disease

• Patients with lung lobectomy or lung volume reduction or lung transplantation

• Patients with α-1 antitrypsin deficiency

• Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period

Other protocol-defined inclusion/exclusion criteria may apply.