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NCT00696020 · ClinicalTrials.gov registry record · Phase 2
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT00696020: Completed Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT00696020 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 360 participants, below the 1,039-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00696020, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 360 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 administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
Primary Outcome
Trough FEV1 (Forced expiratory volume in 1 second) was defined as the mean of the two FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication. The means ar
Conditions Studied
Interventions
- DRUG tiotropium bromide
- DRUG BI 1744 CL/tiotropium bromide fixed dose combination
- DEVICE Respimat® Inhaler
Study Locations (20)
Florida
- 1237.4.0105 Boehringer Ingelheim Investigational Site - Clearwater
- 1237.4.0110 Boehringer Ingelheim Investigational Site - DeLand
- 1237.4.0117 Boehringer Ingelheim Investigational Site - Tampa
South Carolina
- 1237.4.0111 Boehringer Ingelheim Investigational Site - Charleston
- 1237.4.0106 Boehringer Ingelheim Investigational Site - Spartanburg
- 1237.4.0107 Boehringer Ingelheim Investigational Site - Spartanburg
California
- 1237.4.0118 Boehringer Ingelheim Investigational Site - Riverside
- 1237.4.0103 Boehringer Ingelheim Investigational Site - San Diego
Minnesota
- 1237.4.0120 Boehringer Ingelheim Investigational Site - Edina
- 1237.4.0112 Boehringer Ingelheim Investigational Site - Minneapolis
Texas
- 1237.4.0122 Boehringer Ingelheim Investigational Site - Killeen
- 1237.4.0109 Boehringer Ingelheim Investigational Site - New Braunfels
Colorado
- 1237.4.0115 Boehringer Ingelheim Investigational Site - Wheat Ridge
Idaho
- 1237.4.0104 Boehringer Ingelheim Investigational Site - Coeur d'Alene
Missouri
- 1237.4.0119 Boehringer Ingelheim Investigational Site - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2008-06 |
| Phase | Phase 2 |
What the finished NCT00696020 record still lists
NCT00696020 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 1,039-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which tiotropium bromide is the first listed.
NCT00696020 names 20 study sites across 13 states, led by Florida, South Carolina, California.
Frequently Asked Questions
What is clinical trial NCT00696020 about?
NCT00696020 is a clinical study titled "Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)". The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT00696020?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2008-06.
What conditions does trial NCT00696020 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT00696020?
The interventions under investigation include: tiotropium bromide (DRUG), BI 1744 CL/tiotropium bromide fixed dose combination (DRUG), Respimat® Inhaler (DEVICE).
Who is sponsoring clinical trial NCT00696020?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00696020 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Idaho, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00696020's enrollment target sits among peer trials
360 32nd of 74 higher than 43 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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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