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COMPLETED Phase 2

Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

NCT00737100 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 510 participants
Start Date 2008-09
Phase Phase 2

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00737100

The ClinicalTrials.gov registry entry for NCT00737100 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00737100 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Indiana, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00737100?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial