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NCT01634113 · ClinicalTrials.gov registry record · Phase 2

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
102
Enrollment target

NCT01634113 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 102 participants.

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The verdict

NCT01634113, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

Interventions

  • DRUG placebo
  • DRUG tiotropium-bromide

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2012-07
Est. Completion 2014-12
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01634113

The ClinicalTrials.gov registry entry for NCT01634113 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 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 placebo is the first listed.

NCT01634113 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01634113 about?

NCT01634113 is a clinical study titled "Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma". The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

What is the current status of trial NCT01634113?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2012-07. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01634113?

The interventions under investigation include: placebo (DRUG), tiotropium-bromide (DRUG).

Who is sponsoring clinical trial NCT01634113?

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.