A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: NVA237; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856193

2008-006849-28 (EudraCT Number)

CNVA237A2207

Details and patient eligibility

About

This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.

Enrollment: 33 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged greater than 40 years with COPD Current or ex-smokers

Exclusion criteria

• Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Placebo then NVA237 50μg

Placebo Comparator group

Description:

Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.

Treatment:

Drug: NVA237

Drug: Placebo

NVA237 50μg then placebo

Experimental group

Description:

NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.

Treatment:

Drug: NVA237

Drug: Placebo