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NCT01634139 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
403
Enrollment target

NCT01634139 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 403 participants.

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The verdict

NCT01634139, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
403 participants
Enrollment target

Study Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Interventions

  • DRUG Placebo
  • DRUG Tiotropium low dose QD
  • DRUG Tiotropium high dose QD

Trial Details

FieldValue
Enrollment Target 403 participants
Start Date 2012-07
Est. Completion 2015-12
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01634139

The ClinicalTrials.gov registry entry for NCT01634139 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 403 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 3 interventions - of which Placebo is the first listed.

NCT01634139 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01634139 about?

NCT01634139 is a clinical study titled "Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma". The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

What is the current status of trial NCT01634139?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2012-07. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01634139?

The interventions under investigation include: Placebo (DRUG), Tiotropium low dose QD (DRUG), Tiotropium high dose QD (DRUG).

Who is sponsoring clinical trial NCT01634139?

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 Editorial

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.