drugset / Trial / NCT00359788

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

NCT00359788 ↗

Phase 4 Completed 349 enrolled Boehringer Ingelheim
Parallel-groupTreatment

Summary

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

Timeline

Start
2006-07
Primary completion
2008-04
Completion
—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Tiotropium vs Combivent (Ipratropium/Albuterol); p <0.0001; Mean Difference (Final Values) 0.106 (95% CI 0.055 to 0.157); ANCOVA NCT00359788 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipratropium Small molecule — Inhaled
Subject Salbutamol Unknown — Inhaled
Subject Tiotropium Other / unclassified 18 ug Inhaled