drugset / Trial / NCT01969721
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
RandomizedCrossoverDouble-blindTreatment
Summary
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-01
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 250 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 500 ug | Inhaled |
| Subject | Olodaterol | Small molecule | 5 ug | Inhaled |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 2.5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |