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NCT01662986 · ClinicalTrials.gov registry record · Phase 4
Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT01662986: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT01662986 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 79 participants, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01662986, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)
Primary Outcome
Change from baseline of trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study drug. Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG tiotropium bromide
Study Locations (20)
Florida
- 205.478.00200 Boehringer Ingelheim Investigational Site - Jacksonville
- 205.478.00212 Boehringer Ingelheim Investigational Site - Jacksonville
- 205.478.00265 Boehringer Ingelheim Investigational Site - Kissimmee
- 205.478.00246 Boehringer Ingelheim Investigational Site - Lehigh Acres
- 205.478.00248 Boehringer Ingelheim Investigational Site - Miami
- 205.478.00215 Boehringer Ingelheim Investigational Site - Orlando
- 205.478.00261 Boehringer Ingelheim Investigational Site - St. Petersburg
- 205.478.00233 Boehringer Ingelheim Investigational Site - Vero Beach
California
- 205.478.00241 Boehringer Ingelheim Investigational Site - Loma Linda
- 205.478.00240 Boehringer Ingelheim Investigational Site - Long Beach
- 205.478.00237 Boehringer Ingelheim Investigational Site - Torrance
Connecticut
- 205.478.00209 Boehringer Ingelheim Investigational Site - Danbury
- 205.478.00250 Boehringer Ingelheim Investigational Site - Glastonbury
- 205.478.00229 Boehringer Ingelheim Investigational Site - Hartford
Arizona
- 205.478.00208 Boehringer Ingelheim Investigational Site - Flagstaff
- 205.478.00260 Boehringer Ingelheim Investigational Site - Glendale
Georgia
- 205.478.00236 Boehringer Ingelheim Investigational Site - Austell
- 205.478.00205 Boehringer Ingelheim Investigational Site - Lawrenceville
Alabama
- 205.478.00243 Boehringer Ingelheim Investigational Site - Montgomery
Colorado
- 205.478.00231 Boehringer Ingelheim Investigational Site - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2014-04-01 |
| Phase | Phase 4 |
What the finished NCT01662986 record still lists
NCT01662986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01662986 names 20 study sites across 7 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01662986 about?
NCT01662986 is a clinical study titled "Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2". A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospita...
What is the current status of trial NCT01662986?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2012-08-01. Estimated completion is 2014-04-01.
What conditions does trial NCT01662986 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01662986?
The interventions under investigation include: Placebo (DRUG), tiotropium bromide (DRUG).
Who is sponsoring clinical trial NCT01662986?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01662986 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01662986's enrollment target sits among peer trials
79 56th of 74 higher than 19 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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