aMulticenter, randomized, double-blind, placebo-controlled study of 121 adult patients with mild-to-moderate asthma that evaluated the efficacy and safety of AZMACORT 300 mcg BID for 6 weeks.
bP<.0001 vs placebo. Daily albuterol use significantly decreased in the AZMACORT group vs placebo at 6 weeks.
cThe 300-mcg dose was a more precise quantitation of the total dose of active ingredient than the 400-mcg dose.3
- Patients taking AZMACORT 300 mcg BID decreased their mean average daily dosage of albuterol by 49% (or >3 inhalations per day) vs a 10% decrease (or <1 inhalation per day) for the placebo group (P<.0001)4
- AZMACORT demonstrated an 18% mean improvement in FEV1 vs 3% with placebo (P=.0001) at 6 weeks4
- Adverse events were similar in both groups4
- Asthma exacerbations 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.
