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

NCT ID: NCT00856193

Last Updated: 2016-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo then NVA237 50μg

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.

NVA237

Intervention Type DRUG

NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

NVA237 50μg then placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.

NVA237

Intervention Type DRUG

NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

Interventions

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Placebo

Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.

Intervention Type DRUG

NVA237

NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged greater than 40 years with COPD Current or ex-smokers
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Harrison Clinical Research Deutschland GmbH

Albrechtstrasse 14, Munich, Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2008-006849-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNVA237A2207

Identifier Type: -

Identifier Source: org_study_id

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