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Serial FEV1 measurements (shown below as a percent change from test-day baseline) demonstrated that Combivent Inhalation Aerosol produced significantly greater improvement in pulmonary function than either ipratropium bromide or albuterol sulfate when given separately. The median time to onset of a 15% increase in FEV1 was 15 minutes and the median time to peak FEV1 was one hour for Combivent Inhalation Aerosol and its components. The median duration of effect as measured by FEV1 was 4-5 hours for Combivent Inhalation Aerosol compared to 4 hours for ipratropium bromide and 3 hours for albuterol sulfate. Percent Change in Adjusted Mean a FEV1 From Test-Day Baseline – Endpoint Analysis of the Evaluable Data Set
(These graphs not available) These studies demonstrated that each component of Combivent Inhalation Aerosol contributed to the improvement in pulmonary function produced by the combination, especially during the first 4-5 hours after dosing, and that Combivent Inhalation Aerosol was significantly more effective than ipratropium bromide or albuterol sulfate administered alone. Text Continues Below
In the two controlled twelve-week studies, Combivent Inhalation Aerosol did not produce any change in the secondary efficacy parameters including symptom scores, physician global assessments and morning PEFR, all of which were monitored throughout the study period.
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