Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-02-28

Brief Summary

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The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

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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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NVA237 followed by Placebo

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Placebo

Intervention Type DRUG

Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Placebo followed by NVA237

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Placebo

Intervention Type DRUG

Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Interventions

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NVA237

50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Intervention Type DRUG

Placebo

Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
* Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
* Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
* Patients with a post-bronchodilator FEV1 ≥ 40 and \< 70% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
* Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%

Exclusion Criteria

* Pregnant women or nursing mothers
* Women of child-bearing potential
* Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
* Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
* Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
* Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of \< 85%
* Patients with a maximum workload (Wmax) value \< 20 W (as determined by the incremental cycle endurance test) at Visit 2.
* Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
* Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
* Patients with a history of long QT syndrome or whose QTc was prolonged (\> 450 ms for males and \> 470 ms females) at screening (Fredericia's correction)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No