Expired Study
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Palo Alto, California


Purpose:

The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.


Criteria:

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.


Study is Available At:


Original ID:

1205.4


NCT ID:

NCT00122434


Secondary ID:


Study Acronym:


Brief Title:

Dose Finding Study in COPD


Official Title:

A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COP


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

83 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boehringer Ingelheim


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

389


Enrollment Type:

Actual


Overall Contact Information

Official Name:Boehringer Ingelheim Study Coordinator

Study Dates

Start Date:July 2005
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 27, 2017
First Received Date:July 18, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Trough forced expiratory volume (FEV1) response after four weeks of treatment.
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Trough FEV1 response after 1 and 2 weeks
Time Frame:after 1 and 2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Trough FVC response after 1, 2 and 4 weeks
Time Frame:after 1, 2 and 4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks
Time Frame:after 0, 1, 2 and 4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Individual FEV1 and FVC measurements at each time point
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Weekly mean pre-dose morning and evening PEFR
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Physician's Global Evaluation
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:All adverse events
Time Frame:7 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)
Time Frame:4 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:drug plasma concentrations
Time Frame:4 or 7 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:drug urine concentrations
Time Frame:4 or 7 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:BEA 2180 BR
Intervention Type:Drug
Name:tiotropium

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Boehringer Ingelheim

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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