drugset / Trial / NCT02853123
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olodaterol | Small molecule | 5 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 5 ug | Inhaled |