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NCT01663987 · 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 1
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT01663987: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT01663987 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663987, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
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 1)
Primary Outcome
Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.
Interventions
- DRUG Placebo
- DRUG tiotropium bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2014-05-01 |
| Phase | Phase 4 |
What the finished NCT01663987 record still lists
NCT01663987 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01663987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663987 about?
NCT01663987 is a clinical study titled "Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1". 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 NCT01663987?
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 2014-05-01.
What interventions are being tested in trial NCT01663987?
The interventions under investigation include: Placebo (DRUG), tiotropium bromide (DRUG).
Who is sponsoring clinical trial NCT01663987?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01663987's enrollment target sits among peer trials
79 980th of 2000 higher than 1,019 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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