Tuesday, 6 December 2011: 13:15 - 13:30
Isla Mujeres (Cancún Center)
Steven Weinstein, MD
,
Allergy & Asthma Specialists Medical Group, Huntington Beach, CA
Michael Noonan, MD
,
Allergy Associates Research Center, LLC, Portland, OR
William Berger, MD, MBA
,
Allergy & Asthma Associates, Mission Viejo, CA
Heribert Staudinger, MD
,
Merck Research Laboratories, Merck Sharp & Dohme Corp, Kenilworth, NJ
Ariel Teper, MD
,
Allergy/Respiratory, Merck Research Laboratories, Summit, NJ
Background: Mometasone furoate (MF) delivered via dry powder inhaler is an inhaled corticosteroid (ICS) for the treatment of persistent asthma in children ≥4 years. MF 110 µg once daily in the evening (QD PM; approved pediatric dose) and MF 110 µg twice daily (BID) were compared with placebo (PBO) in children aged 4-11 years with persistent asthma previously treated with other ICSs at stable doses for ≥2 weeks before randomization. The primary efficacy variable was change from baseline in % predicted forced expiratory volume in 1 second (FEV
1) at end point; primary results for 296 randomized children were published previously. We investigated the possible relationship between the primary end point and previous ICS use.
Methods: Two post hoc analyses were conducted: one to determine whether children previously using different ICSs responded differently to MF, another to compare the effects of MF vs PBO in the subgroup of children previously using fluticasone propionate (FP).
Results: In post hoc analysis, no significant difference was found in the response to MF in 296 children previously using different ICSs (P=.6372). Most children (160; 54%) previously used FP 88-440 µg/d (median, 176 µg/d). Post hoc analysis of treatment effects in the FP subgroup determined that changes in % predicted FEV1 with MF 110 µg QD PM, MF 110 µg BID, and PBO were 6.4%, 4.3%, and -4.2%, respectively. The difference between both doses of MF and PBO was significant (P<.004).
Conclusions: Previous ICS use did not affect the efficacy of MF in children, and MF 110 µg QD PM significantly improved lung function compared with PBO in children switched from FP.
