Brief Summary

The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed

Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

August 9, 2005

Last Update Submit

October 28, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

Trough forced expiratory volume (FEV1) response
baseline to 24 hours post drug administration
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
after 4 weeks

Secondary Outcomes (11)

Trough FVC response after 4 weeks
after 4 weeks
FEV1 and FVC peak response after 0 and 4 weeks
after 0 and 4 weeks
FVC AUC0-6h after 0 and 4 weeks
after 0 and 4 weeks
Individual FEV1 and FVC measurements at each time point
4 weeks
Weekly mean pre-dose morning and evening PEFR
4 weeks
+6 more secondary outcomes

Interventions

BEA 2180 BRDRUG

tiotropiumDRUG

Eligibility Criteria

Age40 Years - 84 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints). 2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI. 3. Male or female patients 40 years of age or older. 4. Smoker or ex-smoker with a history of more than 10 pack years. 1\. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.