Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00523991 · ClinicalTrials.gov registry record · Phase 4
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 457
- Enrollment target
NCT00523991: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT00523991 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 457 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00523991, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 457 participants
- Enrollment target
Study Summary
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
Primary Outcome
Change = Week 24 Value - Baseline Value
Interventions
- DRUG Placebo
- DRUG tiotropium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2007-04 |
| Phase | Phase 4 |
What the finished NCT00523991 record still lists
NCT00523991 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00523991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00523991 about?
NCT00523991 is a clinical study titled "Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).". A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstruc...
What is the current status of trial NCT00523991?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 457 participants. The study started on 2007-04.
What interventions are being tested in trial NCT00523991?
The interventions under investigation include: Placebo (DRUG), tiotropium (DRUG).
Who is sponsoring clinical trial NCT00523991?
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 NCT00523991's enrollment target sits among peer trials
457 186th of 2000 higher than 1,815 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05856942 · 458 participants · NA
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
- NCT06201676 · 458 participants · Phase 4
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
- NCT04462302 · 456 participants · NA
An Internet-based Program to Help Cancer Survivors Manage Pain
- NCT05820919 · 456 participants · NA
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia