drugset / Trial / NCT02853123

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

NCT02853123

Phase 4 Completed 106 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST). A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.

Timeline

Start
2016-09-22
Primary completion
2017-07-24
Completion
2017-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule 5 ug Inhaled
Comparator Tiotropium Other / unclassified 5 ug Inhaled