drugset / Trial / NCT01794780
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world. The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set. A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
Timeline
- Start
- 2013-02-05
- Primary completion
- 2015-05-25
- Completion
- 2015-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 160 ug | — |
| Subject | Fluticasone | Other / unclassified | 250 ug | — |
| Subject | Fluticasone | Other / unclassified | 500 ug | — |
| Subject | Formoterol | Other / unclassified | 4.5 ug | — |
| Subject | Indacaterol | Other / unclassified | 150 ug | — |
| Subject | Salmeterol | Other / unclassified | 50 ug | — |
| Subject | Theophylline | Small molecule | — | — |
| Subject | Tiotropium | Other / unclassified | 18 ug | — |