Proventil Clinical Trials and Studies

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Proventil Clinical Trials and Studies

Proventil Inhalation Aerosol

In controlled Proventil clinical trials involving adults with asthma, the onset of improvement in pulmonary function was within 15 minutes, as determined by both MMEF (maximum midexpiratory wflow rate) and FEV1 (forced expiratory volume in 1 second). MMEF measurements also showed that near maximum improvement in pulmonary function generally occurs within 60 to 90 minutes following two inhalations of Proventil and that clinically significant improvement generally continues for 3 to 4 hours in most patients. Some patients showed a therapeutic response (defined by maintaining FEV1 values 15% or more above baseline) that was still apparent at 6 hours. Continued effectiveness of Proventil was demonstrated over a 13-week period in these same trials.

In controlled Proventil clinical trials involving children 4 to 12 years of age, FEV1 measurements showed that maximum improvement in pulmonary function occurs within 30 to 60 minutes. The onset of clinically significant (>15%) improvement in FEV1 was observed as soon as 5 minutes following 180 mcg of albuterol in 18 of 30 (60%) children in a controlled dose-ranging study. Clinically significant improvement in FEV1 continued in the majority of patients for 2 hours and in 33% to 47% for 4 hours among 56 patients receiving inhalation aerosol in one pediatric study. In a second study among 48 patients receiving Proventil inhalation aerosol, clinically significant improvement continued in the majority for up to 1 hour and in 23% to 40% for 4 hours. In addition, at least 50% of the patients in both studies achieved an improvement in FEF25%-75% (forced expiratory wflow rate between 25% and 75% of the forced vital capacity) of at least 20% for 2 to 5 hours. Continued effectiveness of albuterol was demonstrated over the 12-week study period.

In other Proventil clinical studies in adults and children, two inhalations of albuterol inhalation aerosol taken approximately 15 minutes before exercise prevented exercise-induced bronchospasm, as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients. One study in adults also evaluated the duration of the prophylactic effect to repeated exercise challenges, which was evident at 4 hours in the majority of patients and at 6 hours in approximately one third of the patients.

Inhalation Solution

In controlled Proventil clinical trials in adults, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEV1. FEV1 measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer and remained close to peak for 2 hours. Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEV1 over baseline values) continued for 3 to 4 hours in most patients, with some patients continuing up to 6 hours.

Published reports of Proventil trials in asthmatic children aged 3 years or older have demonstrated significant improvement in either FEV1 or PEFR within 2 to 20 minutes following single doses of albuterol inhalation solution. An increase of 15% or more in baseline FEV1 has been observed in children aged 5 to 11 years up to 6 hours after treatment with doses of 0.10 mg/kg or higher of albuterol inhalation solution. Single doses of 3, 4, or 10 mg resulted in improvement in baseline PEFR that was comparable in extent and duration to a 2-mg dose, but Proventil doses above 3 mg were associated with heart rate increases of more than 10%.

Capsules for Inhalation

In single, dose-range, crossover trials with Proventil capsules for inhalation in patients 12 years of age and older, the onset of improvement in pulmonary function was within 5 minutes as determined by a 15% increase in forced expiratory volume in 1 second (FEV1) following administration of either a 200- or 400-mcg dose. Maximum increases in FEV1 occurred within 60 minutes following inhalation of either dose. The duration of effect (defined as an increase in FEV1 of 15% or greater in a single-dose study) was 1 to 2 hours after the 200-mcg dose and 3 to 4 hours after the 400 mcg dose. In a single-dose study, an increase in forced expiratory flow rate between 25% and 75% of the forced vital capacity (FEF25%-75%) of 20% or greater continued for 3 to 4 hours after the 200-mcg dose and for 3 to 6 hours following the 400 mcg dose. A therapeutic response continued for 4 hours in the majority of patients and for 6 hours in 38% of the patients following the 400-mcg dose. Twenty-two percent of the patients receiving the 200-mcg dose had a duration of effect of 8 hours.

In 12-week, double-blind, comparative Proventil evaluations in patients 12 years of age and older of one 200-mcg albuterol capsule for inhalation versus two inhalations of albuterol inhalation aerosol, the two dosage regimens were found to be clinically comparable. Based on a 15% or more increase in FEV1 determinations, both provided a therapeutic response that persisted for 2 or 3 hours in 50% of 231 patients aged 12 years and older. Similar results were found in two controlled, 12-week clinical trials involving 204 children aged 4 to 11 years. Both formulations produced a therapeutic response (defined as maintenance of mean increase over baseline of at least 15% in FEV1, or 20% in FEF25%- 75%). Therapeutic improvement of FEF25%-75% persisted for 3 to 5 hours in over 50% of the children throughout the study. Continued effectiveness and safety of albuterol capsules for inhalation were demonstrated over the 12-week study periods in both adults and children.

In other clinical Proventil studies in adults and children, one 200-mcg albuterol capsule for inhalation taken approximately 15 minutes before exercise prevented exercise-induced bronchospasm, as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients. One study in adults also evaluated the duration of the prophylactic effect to repeated exercise challenges, which was evident at 4 hours in the majority of patients and at 6 hours in approximately one third of the patients.

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