Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01122680 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma

A Phase 2 study of Asthma, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
105
Enrollment target
19
Study locations

NCT01122680 is a Phase 2 study of Asthma that has completed, run by Boehringer Ingelheim. The registered enrollment target is 105 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (93% lower). The trial reports 19 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01122680, a Phase 2 study of Asthma, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
105 participants
Enrollment target
19
Study locations

Study Summary

The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.

Conditions Studied

Asthma

Interventions

  • DRUG Placebo
  • DRUG tiotropium bromide
  • DRUG Tiotropium bromide

Study Locations (19)

Other

  • 205.424.49007 Boehringer Ingelheim Investigational Site - Koblenz
  • 205.424.49004 Boehringer Ingelheim Investigational Site - Rosenheim
  • 205.424.49002 Boehringer Ingelheim Investigational Site - Wesel
  • 205.424.37104 Boehringer Ingelheim Investigational Site - Balvi
  • 205.424.37103 Boehringer Ingelheim Investigational Site - Daugavpils
  • 205.424.37105 Boehringer Ingelheim Investigational Site - Rēzekne
  • 205.424.37101 Boehringer Ingelheim Investigational Site - Riga
  • 205.424.37102 Boehringer Ingelheim Investigational Site - Riga
  • 205.424.37001 Boehringer Ingelheim Investigational Site - Vilnius
  • 205.424.37003 Boehringer Ingelheim Investigational Site - Vilnius
  • 205.424.37004 Boehringer Ingelheim Investigational Site - Vilnius
  • 205.424.38604 Boehringer Ingelheim Investigational Site - Kamnik
  • 205.424.38605 Boehringer Ingelheim Investigational Site - Ljubljana
  • 205.424.38602 Boehringer Ingelheim Investigational Site - Maribor

Missouri

  • 205.424.01006 Boehringer Ingelheim Investigational Site - Columbia
  • 205.424.01007 Boehringer Ingelheim Investigational Site - Warrensburg

Colorado

  • 205.424.01002 Boehringer Ingelheim Investigational Site - Denver

Nebraska

  • 205.424.01004 Boehringer Ingelheim Investigational Site - Boys Town

Ohio

  • 205.424.01001 Boehringer Ingelheim Investigational Site - Canton

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2010-05
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01122680

The ClinicalTrials.gov registry entry for NCT01122680 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (93% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01122680 reports 19 study locations spanning 5 distinct geographic areas - top geographies include Other, Missouri, Colorado.

Frequently Asked Questions

What is clinical trial NCT01122680 about?

NCT01122680 is a clinical study titled "Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma". The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 t...

What is the current status of trial NCT01122680?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2010-05.

What conditions does trial NCT01122680 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT01122680?

The interventions under investigation include: Placebo (DRUG), tiotropium bromide (DRUG), Tiotropium bromide (DRUG).

Who is sponsoring clinical trial NCT01122680?

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

Where is trial NCT01122680 being conducted?

This trial has 19 study locations across Colorado, Missouri, Nebraska, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Asthma

All registered trials for this condition

Colorado

All trials with a study site in Colorado

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.