CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 enrolled
Drug / intervention
Placebo twice daily +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01311661
NCT01311661Phase 2Completed
CompareCT.gov

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, Delivered With the Respimat® Inhaler, After 3 Weeks of Olodaterol Once Daily Medium Dose, Twice Daily Low Dose and Placebo or After 3 Weeks of Once Daily High Dose, Twice Daily Medium Dose and Placebo Administration in Patients With Moderate to Severe Persistent Asthma

Boehringer Ingelheim·interventional·Posted Mar 9, 2011·Updated May 1, 2014

In Brief

A Phase 2 clinical trial evaluating Placebo twice daily, Olodaterol low daily dose twice daily, and 3 other interventions for Asthma. Completed, enrolled 206 participants across 36 sites in 6 countries.

Detailed Summary

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustria, Germany, Hungary, Slovakia, Slovenia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2011
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.3 years ago

Interventions

Placebo twice dailydrug

Inhaled Placebo of Olodaterol twice daily

Olodaterol low daily dose twice dailydrug

Inhaled Olodaterol medium daily dose administered as low dose twice daily

Olodaterol medium daily dose twice dailydrug

Inhaled Olodaterol high daily dose administered as medium dose twice daily

Placebo twice dailydrug

Inhaled Placebo of Olodaterol twice daily

Olodaterol high daily dose once daily and placebodrug

Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily

Olodaterol medium daily dose once daily and placebodrug

Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily