Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

Summary

The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Timeline

Start

2009-11

Primary completion

2011-04

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Combivent Respimat vs Combivent Inhalation Aerosol; p < 0.0001; Mean Difference (Final Values) 9.6 (95% CI 6.02 to 13.19); Mixed Models Analysis NCT01019694 ↗

registry analysis (superiority or other test); Combivent Respimat vs Atrovent + Albuterol Aerosols; p = 0.0009; Mean Difference (Final Values) 6.2 (95% CI 2.57 to 9.91); Mixed Models Analysis NCT01019694 ↗

Publications

• Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ipratropium	Small molecule	42 ug	Inhaled
Subject	Ipratropium bromide/albuterol	Unknown	20 ug	Inhaled
Subject	Ipratropium bromide/albuterol	Unknown	36 ug	Inhaled
Subject	Ipratropium bromide/albuterol	Unknown	100 ug	Inhaled
Subject	Ipratropium bromide/albuterol	Unknown	206 ug	Inhaled
Comparator	Salbutamol	Unknown	200 ug	Inhaled

Indications