CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
single dose of 5 mcg +5 moredrug
Likely dose
single dose of 5 mcgfrom 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/NCT01809262
NCT01809262Phase 2Completed
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Single Dose Preliminary Dose-ranging and Safety in Patients With COPD

Boehringer Ingelheim·interventional·Posted Mar 12, 2013·Updated Jun 30, 2014

In Brief

A Phase 2 clinical trial evaluating single dose of 5 mcg, single dose of placebo, and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesNetherlands
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2013
Enrollment StartDec 1, 2005
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.3 years ago

Interventions

single dose of 5 mcgdrug

solution for inhalation

single dose of placebodrug

solution for inhalation

single dose of 40 mcgdrug

solution for inhalation

single dose of 20 mcgdrug

solution for inhalation

single dose of 2 mcgdrug

solution for inhalation

single dose of 10 mcgdrug

solution for inhalation