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NCT00452400 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
A Phase 2 study of Asthma and Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 409
- Enrollment target
- 20
- Study locations
NCT00452400: Completed Phase 2 study of Asthma and Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT00452400 is a Phase 2 study of Asthma and Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 409 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452400, a Phase 2 study of Asthma and Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 409 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).
Primary Outcome
Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.
Conditions Studied
Interventions
- DRUG BI 1744CL
Study Locations (20)
Colorado
- 1222.5.14 Boehringer Ingelheim Investigational Site - Denver
- 1222.5.13 Boehringer Ingelheim Investigational Site - Wheat Ridge
- 1222.5.17 Boehringer Ingelheim Investigational Site - Wheat Ridge
South Carolina
- 1222.5.08 Boehringer Ingelheim Investigational Site - Charleston
- 1222.5.19 Boehringer Ingelheim Investigational Site - Charleston
- 1222.5.06 Boehringer Ingelheim Investigational Site - Spartanburg
Pennsylvania
- 1222.5.05 Boehringer Ingelheim Investigational Site - Hershey
- 1222.5.02 Boehringer Ingelheim Investigational Site - Philadelphia
Texas
- 1222.5.21 Boehringer Ingelheim Investigational Site - Kileen
- 1222.5.01 Boehringer Ingelheim Investigational Site - San Antonio
Alabama
- 1222.5.03 Boehringer Ingelheim Investigational Site - Birmingham
California
- 1222.5.07 Boehringer Ingelheim Investigational Site - Lakewood
Connecticut
- 1222.5.18 Boehringer Ingelheim Investigational Site - Stamford
Florida
- 1222.5.15 Boehringer Ingelheim Investigational Site - Panama City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2007-03 |
| Phase | Phase 2 |
What the finished NCT00452400 record still lists
NCT00452400 is an interventional study that assigns participants to a tested intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which BI 1744CL is the first listed.
NCT00452400 names 20 study sites across 14 states, led by Colorado, South Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00452400 about?
NCT00452400 is a clinical study titled "Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.". The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (ho...
What is the current status of trial NCT00452400?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 409 participants. The study started on 2007-03.
What conditions does trial NCT00452400 study?
This clinical trial studies the following conditions: Asthma, Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT00452400?
The interventions under investigation include: BI 1744CL (DRUG).
Who is sponsoring clinical trial NCT00452400?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00452400 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00452400's enrollment target sits among peer trials
409 90th of 374 higher than 285 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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