Clinical trial
A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol…
NCT00239421 · Boehringer Ingelheim, Industry · Completed
Key facts
| NCT number | NCT00239421 |
|---|---|
| Title | A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD) |
| Official title | A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation Aerosol in Patients With Chronic Obstructive… |
| Lead sponsor | Boehringer Ingelheim, Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Pulmonary Disease, Chronic Obstructive |
| Intervention type | Drug |
| Interventions | Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule), Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d. |
| Enrollment | 605 |
| Start date | Nov 1, 2003 |
| Primary completion | Sep 1, 2004 |
| Completion | Sep 1, 2004 |
| First posted | Oct 17, 2005 |
| Last update posted | Nov 1, 2013 |
| Countries | Austria, Belgium, Denmark, France, Germany, Netherlands, South Africa, Sweden |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: