aA multicenter, randomized, double-blind, placebo-controlled study of 101 adult, mild-to-moderate asthma patients that evaluated the efficacy and safety of AZMACORT 300 mcg BID daily for 6 weeks. The primary measures of efficacy were the mean changes from baseline to 6 weeks in FEV, and 24-hour albuterol use. A secondary measure was the change from baseline to 6 weeks in daytime and nighttime symptoms.
bP<.0001, AZMACORT vs placebo.
cP=.0007, AZMACORT vs placebo.
dThe 300-mcg dose was a more precise quantitation of the total dose of active ingredient than the 400-mcg dose.3
- AZMACORT demonstrated a 17% mean improvement in FEV1 vs
-0.3% with placebo2 - AZMACORT reduced albuterol use by 44% vs 16% with placebo
(P≤.003)2
Adverse events were similar for both groups, with 2 exceptions2
- Lung-related symptoms (eg, increased cough, asthma, dyspnea) occurred more frequently in the placebo group
- Pharyngitis occurred more frequently in patients taking AZMACORT
AZMACORT Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. AZMACORT is also indicated for asthma patients who require systemic corticosteroid administration, where adding AZMACORT may reduce or eliminate the need for the systemic corticosteroids.
AZMACORT is NOT indicated for the relief of acute bronchospasm.
