Capsules for Inhalation

In single, dose-range, crossover trials with albuterol 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 (FEF_25%-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 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 FEF_{25%- 75%}). Therapeutic improvement of FEF_25%-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 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.

Bookmark this page: