ATROVENT HFA Inhalation Aerosol (42 mcg) was shown to be clinically comparable to ATROVENT Inhalation Aerosol CFC (42 mcg).

Figure 1 - Day 1 and Day 85 (Primary Endpoint) Results

In this study, both Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations were equally effective in patients over 65 years of age and under 65 years of age.

The median time to improvement in pulmonary function (FEV₁ increase of 15% or more) was within approximately 15 minutes, reached a peak in 1-2 hours, and persisted for 2 to 4 hours in the majority of the patients. Improvements in Forced Vital Capacity (FVC) were also demonstrated.

The other study was a 12-week, randomized, double-blind, active-controlled clinical study in 174 adults with COPD, in which ATROVENT HFA Inhalation Aerosol 42 mcg (n=118) was compared to ATROVENT Inhalation Aerosol CFC 42 mcg (n=56). Safety and efficacy of HFA and CFC formulations were shown to be comparable.

The bronchodilatory efficacy and comparability of Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol vs. Atrovent® (ipratropium bromide) Inhalation Aerosol CFC were also studied in a one-year open-label safety and efficacy study in 456 COPD patients. The safety and efficacy of HFA and CFC formulations were shown to be comparable.

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