Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00737100 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
A Phase 2 study of Cystic Fibrosis, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT00737100: Completed Phase 2 study of Cystic Fibrosis, sponsored by Boehringer Ingelheim.
NCT00737100 is a Phase 2 study of Cystic Fibrosis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 510 participants, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (190% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00737100, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
Primary Outcome
Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Conditions Studied
Interventions
- DRUG Placebo Respimat
- DRUG Tiotropium bromide 5 mcg
- DRUG tiotropium bromide-low dose-2.5mcg
Study Locations (20)
Florida
- 205.339.023 Boehringer Ingelheim Investigational Site - Jacksonville
- 205.339.021 Boehringer Ingelheim Investigational Site - Miami
- 205.339.030 Boehringer Ingelheim Investigational Site - Orlando
- 205.339.031 Boehringer Ingelheim Investigational Site - Orlando
Indiana
- 205.339.014 Boehringer Ingelheim Investigational Site - Indianapolis
- 205.339.022 Boehringer Ingelheim Investigational Site - Indianapolis
- 205.339.013 Boehringer Ingelheim Investigational Site - South Bend
Michigan
- 205.339.017 Boehringer Ingelheim Investigational Site - Ann Arbor
- 205.339.025 Boehringer Ingelheim Investigational Site - Detroit
- 205.339.016 Boehringer Ingelheim Investigational Site - Grand Rapids
New Jersey
- 205.339.029 Boehringer Ingelheim Investigational Site - Long Branch
- 205.339.009 Boehringer Ingelheim Investigational Site - Morristown
Oklahoma
- 205.339.020 Boehringer Ingelheim Investigational Site - Oklahoma City
- 205.339.032 Boehringer Ingelheim Investigational Site - Oklahoma City
Arizona
- 205.339.006 Boehringer Ingelheim Investigational Site - Tucson
California
- 205.339.019 Boehringer Ingelheim Investigational Site - San Diego
Iowa
- 205.339.001 Boehringer Ingelheim Investigational Site - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00737100 record still lists
NCT00737100 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (190% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo Respimat is the first listed.
NCT00737100 names 20 study sites across 11 states, led by Florida, Indiana, Michigan.
Frequently Asked Questions
What is clinical trial NCT00737100 about?
NCT00737100 is a clinical study titled "Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis". This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator effic...
What is the current status of trial NCT00737100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 510 participants. The study started on 2008-09.
What conditions does trial NCT00737100 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00737100?
The interventions under investigation include: Placebo Respimat (DRUG), Tiotropium bromide 5 mcg (DRUG), tiotropium bromide-low dose-2.5mcg (DRUG).
Who is sponsoring clinical trial NCT00737100?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00737100 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00737100's enrollment target sits among peer trials
510 12th of 169 higher than 158 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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
-
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
RECRUITING · Phase 2
-
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
RECRUITING · Phase 2
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis
RECRUITING · Phase 2
-
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
RECRUITING · Phase 2
-
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
RECRUITING · Phase 2
-
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
ACTIVE NOT RECRUITING · Phase 2
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
- NCT03922542 · 510 participants · Phase 2
Comparison of Standard vs. Accelerated Corneal Crosslinking
- NCT04634552 · 510 participants · Phase 2
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
- NCT05164744 · 510 participants
Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors
- NCT05451004 · 510 participants · Phase 3
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
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