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NCT00720499 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
141
Enrollment target

NCT00720499: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT00720499 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 141 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00720499, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
141 participants
Enrollment target

Study Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Primary Outcome

Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).

Interventions

  • DEVICE Respimat® Inhaler
  • DRUG BI 1744 CL plus tiotropium bromide

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2008-07
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT00720499 record still lists

NCT00720499 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Respimat® Inhaler is the first listed.

NCT00720499 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00720499 about?

NCT00720499 is a clinical study titled "Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)". The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

What is the current status of trial NCT00720499?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2008-07.

What interventions are being tested in trial NCT00720499?

The interventions under investigation include: Respimat® Inhaler (DEVICE), BI 1744 CL plus tiotropium bromide (DRUG).

Who is sponsoring clinical trial NCT00720499?

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 NCT00720499's enrollment target sits among peer trials

141 510th of 2000 higher than 1,489 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00720499, the US trial registry maintained by the National Library of Medicine. NCT00720499 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.