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NCT00240435 · ClinicalTrials.gov registry record · Phase 3

12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
491
Enrollment target

NCT00240435 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 491 participants.

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The verdict

NCT00240435, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
491 participants
Enrollment target

Study Summary

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Interventions

  • DEVICE 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
  • DEVICE 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Trial Details

FieldValue
Enrollment Target 491 participants
Start Date 2002-11
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00240435

The ClinicalTrials.gov registry entry for NCT00240435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler is the first listed.

NCT00240435 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00240435 about?

NCT00240435 is a clinical study titled "12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD". The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the...

What is the current status of trial NCT00240435?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 491 participants. The study started on 2002-11.

What interventions are being tested in trial NCT00240435?

The interventions under investigation include: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler (DEVICE), 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler (DEVICE).

Who is sponsoring clinical trial NCT00240435?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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.