- Email: [email protected]
Assessment of the effective daily dose for mometasone furoate dry powder inhaler in the treatment of persistent asthma
the PLA and FP groups, respectively, at endpoint. More PLA patients (12%) discontinued due to TF compared with FP-treated patients (5%) (p=0.034). CONCLUSION: Treatment with FP HFA 88mcg BID for 12 weeks significantly improves asthma control in 1 to <4 year-olds with asthma. Funding: GlaxoSmithKline, Inc. 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
16
Assessment of the Effective Daily Dose for Mometasone Furoate Dry Powder Inhaler in the Treatment of Persistent Asthma H. Staudinger1, D. Gates1, W. Kuo1, L. Shneyer1, K. Heithoff2; 1Schering-Plough Research Institute, Kenilworth, NJ, 2Schering-Plough Pharmaceuticals, Kenilworth, NJ. RATIONALE: Mometasone furoate dry powder inhaler (MF-DPI) has been evaluated in several clinical studies for treatment of asthma at an initial dose of 400 mcg/day in mild and moderate persistent asthma. We analyzed the odds that asthma control can be maintained at a maintenance dose of 200 mcg/day. METHODS: Data were pooled from 4 placebo-controlled trials of MFDPI with regard to asthma severity based on GINA guidelines. Severity was stratified into Steps 2 (mild persistent asthma) and 3 (moderate persistent asthma). The magnitude of response was based on combined increases in FEV1 (≥0.15 L) and AM PEF (≥10 L/min). Odds ratios (OR) and 95% confidence intervals were calculated for responses with MF-DPI 200 mcg/day vs 400 mcg/day, and MF-DPI 200 mcg/day vs placebo. RESULTS: For Step 2 patients (n = 126), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 1.0435 (0.4427, 2.4596); for MF-DPI 200 mcg/day vs placebo the OR was 3.1084 (1.0735, 8.9930). For Step 3 patients (n = 406), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 0.4990 (0.3054, 0.8159), and for MF-DPI 200 mcg/day vs placebo the OR was 2.3421 (1.3119, 4.1817). CONCLUSIONS: Step 2 subjects had approximately equal odds of responding to 200 mcg/day or 400 mcg/day. Although an apparent dose response was seen in Step 3 subjects, a substantial number of patients can be maintained on 200 mcg/day. Funding: Schering-Plough
17
Onset of Improvements of Lung Function With Mometasone Furoate Dry Powder Inhaler (MF-DPI) in ICS-Naïve 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
18
Omalizumab Significantly Improves Quality of Life in Patients With Severe Persistent Asthma B. Chipps1, J. Corren2, A. Finn3, S. Hedgecock4, H. Fox4, M. Blogg4; 1Capital Allergy and Respiratory Disease Center, Sacramento, CA, 2Allergy Research Foundation Inc., Los Angeles, CA, 3National Allergy, Asthma and Urticaria Centers of Charleston, Charleston, SC, 4Novartis Horsham Research Centre, Horsham, UNITED KINGDOM. RATIONALE: Severe persistent asthma has a significant impact on the patient’s quality of life. We evaluated the effect of add-on omalizumab (Xolair®) therapy on asthma-related quality of life using the well-validated Juniper Adult Asthma Quality of Life Questionnaire (AQLQ). METHODS: The effect of omalizumab on asthma-related quality of life has been evaluated in 6 controlled clinical trials in patients with IgEmediated asthma. Omalizumab was added to current asthma therapy and compared with placebo (in 5 double-blind studies) or with current asthma therapy alone in an open-label study. Asthma-related quality of life was assessed using the AQLQ (individual domains, total score and clinically meaningful improvements). RESULTS: The 6 studies included 2548 patients. In each study, ≥90% of patients had severe persistent asthma according to the GINA 2002 classification. Quality of life data were available for 2253 patients, with 1221 patients receiving omalizumab and 1032 control patients. In all studies, omalizumab produced significantly greater improvements in total AQLQ score compared with placebo (p<0.05). In addition, a significantly greater proportion of patients receiving omalizumab achieved a clinically meaningful ≥0.5-point improvement from baseline in AQLQ score compared with placebo/control patients in 5 of the 6 studies (p<0.01). CONCLUSIONS: Add-on omalizumab therapy significantly improves asthma-related quality of life in patients with severe persistent asthma. Funding: Novartis Pharma AG and Genentech
19
SATURDAY
Abstracts S5
J ALLERGY CLIN IMMUNOL VOLUME 115, NUMBER 2
16
Assessment of the Effective Daily Dose for Mometasone Furoate Dry Powder Inhaler in the Treatment of Persistent Asthma H. Staudinger1, D. Gates1, W. Kuo1, L. Shneyer1, K. Heithoff2; 1Schering-Plough Research Institute, Kenilworth, NJ, 2Schering-Plough Pharmaceuticals, Kenilworth, NJ. RATIONALE: Mometasone furoate dry powder inhaler (MF-DPI) has been evaluated in several clinical studies for treatment of asthma at an initial dose of 400 mcg/day in mild and moderate persistent asthma. We analyzed the odds that asthma control can be maintained at a maintenance dose of 200 mcg/day. METHODS: Data were pooled from 4 placebo-controlled trials of MFDPI with regard to asthma severity based on GINA guidelines. Severity was stratified into Steps 2 (mild persistent asthma) and 3 (moderate persistent asthma). The magnitude of response was based on combined increases in FEV1 (≥0.15 L) and AM PEF (≥10 L/min). Odds ratios (OR) and 95% confidence intervals were calculated for responses with MF-DPI 200 mcg/day vs 400 mcg/day, and MF-DPI 200 mcg/day vs placebo. RESULTS: For Step 2 patients (n = 126), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 1.0435 (0.4427, 2.4596); for MF-DPI 200 mcg/day vs placebo the OR was 3.1084 (1.0735, 8.9930). For Step 3 patients (n = 406), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 0.4990 (0.3054, 0.8159), and for MF-DPI 200 mcg/day vs placebo the OR was 2.3421 (1.3119, 4.1817). CONCLUSIONS: Step 2 subjects had approximately equal odds of responding to 200 mcg/day or 400 mcg/day. Although an apparent dose response was seen in Step 3 subjects, a substantial number of patients can be maintained on 200 mcg/day. Funding: Schering-Plough
17
Onset of Improvements of Lung Function With Mometasone Furoate Dry Powder Inhaler (MF-DPI) in ICS-Naïve 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
18
Omalizumab Significantly Improves Quality of Life in Patients With Severe Persistent Asthma B. Chipps1, J. Corren2, A. Finn3, S. Hedgecock4, H. Fox4, M. Blogg4; 1Capital Allergy and Respiratory Disease Center, Sacramento, CA, 2Allergy Research Foundation Inc., Los Angeles, CA, 3National Allergy, Asthma and Urticaria Centers of Charleston, Charleston, SC, 4Novartis Horsham Research Centre, Horsham, UNITED KINGDOM. RATIONALE: Severe persistent asthma has a significant impact on the patient’s quality of life. We evaluated the effect of add-on omalizumab (Xolair®) therapy on asthma-related quality of life using the well-validated Juniper Adult Asthma Quality of Life Questionnaire (AQLQ). METHODS: The effect of omalizumab on asthma-related quality of life has been evaluated in 6 controlled clinical trials in patients with IgEmediated asthma. Omalizumab was added to current asthma therapy and compared with placebo (in 5 double-blind studies) or with current asthma therapy alone in an open-label study. Asthma-related quality of life was assessed using the AQLQ (individual domains, total score and clinically meaningful improvements). RESULTS: The 6 studies included 2548 patients. In each study, ≥90% of patients had severe persistent asthma according to the GINA 2002 classification. Quality of life data were available for 2253 patients, with 1221 patients receiving omalizumab and 1032 control patients. In all studies, omalizumab produced significantly greater improvements in total AQLQ score compared with placebo (p<0.05). In addition, a significantly greater proportion of patients receiving omalizumab achieved a clinically meaningful ≥0.5-point improvement from baseline in AQLQ score compared with placebo/control patients in 5 of the 6 studies (p<0.01). CONCLUSIONS: Add-on omalizumab therapy significantly improves asthma-related quality of life in patients with severe persistent asthma. Funding: Novartis Pharma AG and Genentech
19
SATURDAY
Abstracts S5
J ALLERGY CLIN IMMUNOL VOLUME 115, NUMBER 2