Improvements in health-related quality of life with once-daily (evening) or twice-daily dosing of mometasone furoate dry powder inhaler (MF-DPI) in children with asthma

Abstract

16 Improvements in Health-Related Quality of Life With Once-Daily (Evening) or Twice-Daily Dosing of Mometasone Furoate Dry Powder Inhaler (MF-DPI) in Children With Asthma M. Noonan1, M. E. Ruff2, P. Chervinsky3, W. Berger4; 1Allergy Associates Research, Portland, OR, 2Pharmaceutical Research & Consulting, Dallas, TX, 3New England Clinical Studies, North Dartmouth, MA, 4Southern California Research, Mission Viejo, CA. RATIONALE: To evaluate the effects of mometasone furoate dry powder inhaler (MF-DPI) 100 mcg administered once daily in the evening (QD PM) on health-related quality of life (HQOL) in children with asthma previously maintained on inhaled corticosteroids (ICS). METHODS: A randomized, placebo-controlled, 12-week study in children (4 11 years of age) with asthma evaluated (as secondary efficacy variables) the HQOL effects of MF-DPI 100 mcg QD PM, MF-DPI 100 mcg BID, and placebo. The HQOL data were collected using the Child Health Questionnaire Parent Form (CHQ-PF28) and an asthma-specific module (ASM). The primary HQOL variables were changes from baseline in the physical summary score (PSS) of CHQ-PF28, and in the disability domain of the ASM. Data for the HQOL domains were analyzed for Week 8, Week 12 and endpoint using ANOVA. RESULTS: Of 296 randomized subjects, 292 (99%) completed both HQOL questionnaires at baseline and endpoint. Mean HQOL scores were similar among treatment groups at baseline, and suggested impaired function and well-being compared with the general population. At endpoint, the mean PSS improved significantly with MF-DPI 100 mcg QD PM vs placebo (3.4 and -2.1, respectively; p = 0.002). The mean ASM-disability score also improved significantly with MF-DPI 100 mcg QDPM vs placebo (9.2 and 0.3, respectively; p<0.001). Mean PSS and ASM-disability improvements with MF-DPI 100 mcg BID (2.3 and 6.8, respectively) were similar to those observed with MF-DPI 100 mcg QD PM. CONCLUSIONS: Treatment with MF-DPI 100 mcg QD PM significantly improves quality of life in children with asthma. Funding: Schering-Plough 18 Onset of Improvements of Lung Function With Mometasone Furoate Dry Powder Inhaler (MF-DPI) in ICS-Naive Patients With Asthma B. Prenner1, R. Berkowitz2, G. W. Bensch3, B. N. Lutsky4; 1Allergy Associates Medical Group, San Diego, CA, 2Rx Research, Atlanta Allergy & Asthma Clinic, Marietta, GA, 3Allergy, Immunology, and Asthma Medical Group, Stockton, CA, 4Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: To evaluate the onset of improvements in lung function with mometasone furoate dry powder inhaler (MF-DPI) administered as 200 mcg once daily in the evening (QD PM). METHODS: Randomized, double-blind, placebo-controlled, efficacy and safety study of 12 weeks of treatment with MF-DPI 200 mcg QD PM in subjects ≥12 years of age with asthma previously maintained on shortacting beta-agonists (SABA) alone. Changes from baseline in forced expiratory volume in 1 second (FEV1) at Weeks 1, 2, 4, 8, 12 and endpoint (primary variable) were assessed. RESULTS: Mean improvement from baseline in FEV1 was 11.7% at Week 1 (first assessment) in the MF-DPI group, compared with a 4.3% increase in the placebo group (p<.01). FEV1 improved consistently with MF-DPI throughout the study period, and improvements with MF-DPI at each assessment were significantly greater than those with placebo (p<.01). A mean increase of 18.5% was observed at Week 12, compared with a 7.6% increase with placebo (p<.01). At endpoint, the mean increase from baseline in FEV1 was 16.8% on MF-DPI, compared with 6% on placebo (p<.01). Treatment with MF-DPI was well tolerated, with no unusual or unexpected adverse events reported. No clinically meaningful changes in laboratory parameters, vital signs, or physical examinations were noted in either treatment group. CONCLUSIONS: In patients previously maintained with SABA alone, MF-DPI 200 mcg QD PM improved lung function rapidly and provided consistent improvements with continued treatment. The results reported here support and extend those observed in other studies in which MF-DPI 200 mcg QD PM was evaluated. Funding: Schering-Plough Research Institute