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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 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.

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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

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

515 total trials

What the Registry Record Tells You About NCT00737100

The ClinicalTrials.gov registry entry for NCT00737100 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (190% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.