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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00240435 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 491 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Boehringer Ingelheim

515 total trials

What the finished NCT00240435 record still lists

NCT00240435 is an interventional study that assigns participants to a tested intervention. The registered 491 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00240435's enrollment target sits among peer trials

491 781st of 2000 higher than 1,219 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT00240435, the US trial registry maintained by the National Library of Medicine. NCT00240435 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.