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Efficacy of Twice Daily Fluticasone Propionate and Formoterol Fumarate Combination Administered Using an HFA pMDI in Patients with Moderate to Severe Asthma
Abstracts S157
J ALLERGY CLIN IMMUNOL VOLUME 123, NUMBER 2
Evaluating Asthma Control and Pulmonary Function with Ciclesonide 80 mG Twice Daily or 160 mG Once Daily in the Morning in Patients Who Have Previously Received Another Inhaled Corticosteroid A. Nayak1, M. Noonan2, W. Andrews3, S. Weinstein4; 1Sneeze, Wheeze and Itch Associates, Normal, IL, 2Allergy Associates Research Center, Portland, OR, 3Sepracor, Marlborough, MA, 4Allergy and Asthma Specialists Medical Group and Research Center, Huntington Beach, CA. RATIONALE: When assessing the effectiveness of asthma controller medications, it is important to evaluate both pulmonary function and asthma control variables. Here we report asthma control and pulmonary function results from a study of ciclesonide, an inhaled corticosteroid (ICS), in patients with mild-to-moderate asthma previously receiving an ICS. METHODS: In this 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, patients aged 12 years with stable mildto-moderate persistent asthma treated prior to study entry with another ICS were randomized to receive ciclesonide 80 mg twice daily (CIC80bid; n 5 149), ciclesonide 160 mg once daily AM (CIC160qd; n 5 150) or placebo (n 5 147). The primary endpoint was change in FEV1 from baseline to Week 12. Days with asthma control were defined as those without asthma symptom scores, nighttime awakenings and/or albuterol use. RESULTS: FEV1 improved (least squares mean change) from baseline to Week 12 with both CIC80bid (0.07L) and CIC160qd (0.01L) versus a decrease with placebo (-0.12L); FEV1 improvement was significantly greater for both CIC doses compared with placebo (CIC80bid, p < 0.0001; CIC160qd, p 5 0.0006). The percentage of asthma control days and asthma symptom-free days were highest in the CIC80bid group (36.9 and 44.4%, respectively), followed by the CIC160qd group (32.4 and 37.8%, respectively) and the placebo group (27.6 and 32.3%, respectively). The proportion of days with nighttime awakenings was lower in both ciclesonide groups versus placebo (CIC80bid, 4.9%; CIC160qd, 6.5%; placebo, 10.3%). CONCLUSIONS: Ciclesonide was effective at maintaining lung function and increasing the number of asthma controlled days in patients with stable mild-to-moderate asthma previously treated with another ICS.
599
Response to Once-Daily Therapy With Inhaled Mometasone Furoate in Children Aged 4-11 Years With Persistent Asthma M. Noonan1, S. F. Weinstein2, W. E. Berger3, H. Staudinger4; 1Allergy Associates Research Center, LLC, Portland, OR, 2Allergy & Asthma Specialists Research Group, Huntington Beach, CA, 3Allergy & Asthma Associates of Southern California, Mission Viejo, CA, 4Schering-Plough Corporation, Kenilworth, NJ. RATIONALE: Regular follow-up contact with asthma patients is essential because it enables physicians to assess the patients’ level of asthma control in response to therapy. We evaluated the physician-evaluated response to therapy after treatment with mometasone furoate administered via a drypowder inhaler (MF-DPI) in children with persistent asthma previously treated with other inhaled corticosteroids. METHODS: MF-DPI was evaluated in a 12-week, randomized, placebocontrolled, double-blind study involving children 4-11 years old with mildto-moderate persistent asthma. Patients received either MF-DPI 100 mg once-daily in the evening (QD PM), the approved pediatric dose, MFDPI 100 mg twice-daily (BID), or placebo. Primary efficacy and safety results have been presented elsewhere. Patients’ responses to therapy were assessed by the attending physician at every visit from day 4 through week 12. These responses were scored as the change from baseline using a 5-point scale: 1 5 much improved, 2 5 improved, 3 5 no change, 4 5 worse, 5 5 much worse. Results were analyzed using a Fisher exact test. RESULTS: 296 children were randomized. Mean response scores were significantly better with MF-DPI 100 mg QD PM vs placebo from week 1 (2.33 vs 2.68, P < 0.001) until the end of the trial (week 12; 2.07 vs 2.99, P 5 0.035). Scores were also significantly better with MF-DPI 100 mg BID vs placebo from weeks 1 to 11 (P < 0.05). The physician-based assessments were consistent with the primary efficacy results which demonstrated that children achieved and maintained asthma control.
CONCLUSIONS: Children treated with MF-DPI 100 mg QD PM experienced consistently sustained significant improvements in physician-evaluated responses to therapy throughout the length of the trial.
600
Efficacy of Twice Daily Fluticasone Propionate and Formoterol Fumarate Combination Administered Using an HFA pMDI in Patients with Moderate to Severe Asthma J. Corren1, L. E. Mansfield2, K. Kaiser3, C. L. Renz4, R. I. Jain4, R. J. Perdok4, T. T. Doan4; 1Allergy Research Foundation, Los Angeles, CA, 2 Western Sky Medical Research, El Paso, TX, 3SkyePharma, Muttenz, Switzerland, 4Abbott Laboratories, Abbott Park, IL. RATIONALE: Fluticasone propionate (FP) and formoterol fumarate (FM) represent two efficacious medications for the treatment of persistent asthma. In order to assess the efficacy of the combination of these two medications, FP/FM (in a single inhaler) was compared to FP, FM or placebo in adolescent and adult patients with moderate to severe asthma. METHODS: This was a 12-week, randomized, double-blind, placebocontrolled, parallel group, stratified, multi-center study. Following a 2week run-in period with FP, 443 patients were assigned to FP/FM HFA pMDI (125/5 mg, 2 inhalations BID), FP HFA pMDI (125 mg, 2 inhalations BID), FM HFA pMDI (5 mg, 2 inhalations BID), or placebo. RESULTS: 432 patients (mean 6 SD): age 43.1 6 15.47 years, asthma duration 20.13 6 14.92 years, FEV1 2.11 6 0.57 (L), FEV1% predicted 65.0 6 13.23%, and reversibility 26.76 6 13.55% were assessed. Mean change (6 SE) in FEV1, from pre-dose at baseline to pre-dose at week 12 was significantly greater (P < 0.001) for FP/FM (0.184 6 0.043 L) than FM alone (-0.004 6 0.041 L). Mean change (6 SE) in FEV1 from pre-dose at baseline to 2-hours post-dose at week 12 was significantly greater (P 5 0.006) for FP/FM (0.357 6 0.040 L) than FP alone (0.211 6 0.039 L). Reports of adverse events were low and similar across all treatment groups. CONCLUSIONS: Combination FP/FM was a more effective treatment for asthma than monotherapy with either FP or FM in patients with moderate to severe asthma.
601
Probiotics as an Adjunctive Treatment in Allergic Diseases of Respiratory Tract: A Systematic Review of Benefits and Risks R. R. Das, M. Singh, N. Gupta, N. Shafiq; PGIMER, Chandigarh, India. RATIONALE: A recent meta-analysis of randomized trials showed insufficient evidence to support use of probiotics in prevention of respiratory allergy. We conducted a systematic review on role of probiotics as an adjunctive treatment in respiratory allergy. METHODS: A systematic search of published literature was done. Randomized Controlled Trials (RCTs) (quality score 3) of probiotics in treatment of respiratory allergy were included. A pre-defined set of outcome measures were assessed. Weighted mean difference (WMD) with 95%confidence interval (CI) was calculated using RevMan(version 4.2.10). RESULTS: After screening, 5 RCTs (Japan 5 3, Italy 5 1, Finland 5 1) spanning over 7 years including 423 subjects qualified for inclusion. Due to differences in the outcomes, the data could not be pooled for majority of the outcomes. Among studies on asthma, probiotic use led to a significant worsening in symptom and medication scores; -4.05(-5.21,-2.88) and 1.50(1.13,1.87) respectively. However, there was significant reduction in time free from an episode of asthma[0.80 (0.62,0.98)] without any significant effect on duration of an episode [-0.47(-1.47,0.53)]. Among studies on allergic rhinitis, one study reported statistically significant benefit in nasal symptom-medication score (WMD could not calculated due to paucity of data) and another reported decrease in annual number of rhinitis episode [-1.6(-3.15,-0.05)].In the same study combined time free from rhinitis and asthma was significantly improved with probiotic use [1.40(1.30,1.50)].Of the immunological parameters, there was significant reduction in IgE level, pooled WMD (95%CI) -25.06 (-48.42,-1.70). Side-effects (GI upset, cold) were not significant. CONCLUSIONS: The evidence on probiotics in treatment of respiratory allergy is limited.Large clinical trials with evaluation of clinically relevant outcomes are needed.
MONDAY
598
J ALLERGY CLIN IMMUNOL VOLUME 123, NUMBER 2
Evaluating Asthma Control and Pulmonary Function with Ciclesonide 80 mG Twice Daily or 160 mG Once Daily in the Morning in Patients Who Have Previously Received Another Inhaled Corticosteroid A. Nayak1, M. Noonan2, W. Andrews3, S. Weinstein4; 1Sneeze, Wheeze and Itch Associates, Normal, IL, 2Allergy Associates Research Center, Portland, OR, 3Sepracor, Marlborough, MA, 4Allergy and Asthma Specialists Medical Group and Research Center, Huntington Beach, CA. RATIONALE: When assessing the effectiveness of asthma controller medications, it is important to evaluate both pulmonary function and asthma control variables. Here we report asthma control and pulmonary function results from a study of ciclesonide, an inhaled corticosteroid (ICS), in patients with mild-to-moderate asthma previously receiving an ICS. METHODS: In this 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, patients aged 12 years with stable mildto-moderate persistent asthma treated prior to study entry with another ICS were randomized to receive ciclesonide 80 mg twice daily (CIC80bid; n 5 149), ciclesonide 160 mg once daily AM (CIC160qd; n 5 150) or placebo (n 5 147). The primary endpoint was change in FEV1 from baseline to Week 12. Days with asthma control were defined as those without asthma symptom scores, nighttime awakenings and/or albuterol use. RESULTS: FEV1 improved (least squares mean change) from baseline to Week 12 with both CIC80bid (0.07L) and CIC160qd (0.01L) versus a decrease with placebo (-0.12L); FEV1 improvement was significantly greater for both CIC doses compared with placebo (CIC80bid, p < 0.0001; CIC160qd, p 5 0.0006). The percentage of asthma control days and asthma symptom-free days were highest in the CIC80bid group (36.9 and 44.4%, respectively), followed by the CIC160qd group (32.4 and 37.8%, respectively) and the placebo group (27.6 and 32.3%, respectively). The proportion of days with nighttime awakenings was lower in both ciclesonide groups versus placebo (CIC80bid, 4.9%; CIC160qd, 6.5%; placebo, 10.3%). CONCLUSIONS: Ciclesonide was effective at maintaining lung function and increasing the number of asthma controlled days in patients with stable mild-to-moderate asthma previously treated with another ICS.
599
Response to Once-Daily Therapy With Inhaled Mometasone Furoate in Children Aged 4-11 Years With Persistent Asthma M. Noonan1, S. F. Weinstein2, W. E. Berger3, H. Staudinger4; 1Allergy Associates Research Center, LLC, Portland, OR, 2Allergy & Asthma Specialists Research Group, Huntington Beach, CA, 3Allergy & Asthma Associates of Southern California, Mission Viejo, CA, 4Schering-Plough Corporation, Kenilworth, NJ. RATIONALE: Regular follow-up contact with asthma patients is essential because it enables physicians to assess the patients’ level of asthma control in response to therapy. We evaluated the physician-evaluated response to therapy after treatment with mometasone furoate administered via a drypowder inhaler (MF-DPI) in children with persistent asthma previously treated with other inhaled corticosteroids. METHODS: MF-DPI was evaluated in a 12-week, randomized, placebocontrolled, double-blind study involving children 4-11 years old with mildto-moderate persistent asthma. Patients received either MF-DPI 100 mg once-daily in the evening (QD PM), the approved pediatric dose, MFDPI 100 mg twice-daily (BID), or placebo. Primary efficacy and safety results have been presented elsewhere. Patients’ responses to therapy were assessed by the attending physician at every visit from day 4 through week 12. These responses were scored as the change from baseline using a 5-point scale: 1 5 much improved, 2 5 improved, 3 5 no change, 4 5 worse, 5 5 much worse. Results were analyzed using a Fisher exact test. RESULTS: 296 children were randomized. Mean response scores were significantly better with MF-DPI 100 mg QD PM vs placebo from week 1 (2.33 vs 2.68, P < 0.001) until the end of the trial (week 12; 2.07 vs 2.99, P 5 0.035). Scores were also significantly better with MF-DPI 100 mg BID vs placebo from weeks 1 to 11 (P < 0.05). The physician-based assessments were consistent with the primary efficacy results which demonstrated that children achieved and maintained asthma control.
CONCLUSIONS: Children treated with MF-DPI 100 mg QD PM experienced consistently sustained significant improvements in physician-evaluated responses to therapy throughout the length of the trial.
600
Efficacy of Twice Daily Fluticasone Propionate and Formoterol Fumarate Combination Administered Using an HFA pMDI in Patients with Moderate to Severe Asthma J. Corren1, L. E. Mansfield2, K. Kaiser3, C. L. Renz4, R. I. Jain4, R. J. Perdok4, T. T. Doan4; 1Allergy Research Foundation, Los Angeles, CA, 2 Western Sky Medical Research, El Paso, TX, 3SkyePharma, Muttenz, Switzerland, 4Abbott Laboratories, Abbott Park, IL. RATIONALE: Fluticasone propionate (FP) and formoterol fumarate (FM) represent two efficacious medications for the treatment of persistent asthma. In order to assess the efficacy of the combination of these two medications, FP/FM (in a single inhaler) was compared to FP, FM or placebo in adolescent and adult patients with moderate to severe asthma. METHODS: This was a 12-week, randomized, double-blind, placebocontrolled, parallel group, stratified, multi-center study. Following a 2week run-in period with FP, 443 patients were assigned to FP/FM HFA pMDI (125/5 mg, 2 inhalations BID), FP HFA pMDI (125 mg, 2 inhalations BID), FM HFA pMDI (5 mg, 2 inhalations BID), or placebo. RESULTS: 432 patients (mean 6 SD): age 43.1 6 15.47 years, asthma duration 20.13 6 14.92 years, FEV1 2.11 6 0.57 (L), FEV1% predicted 65.0 6 13.23%, and reversibility 26.76 6 13.55% were assessed. Mean change (6 SE) in FEV1, from pre-dose at baseline to pre-dose at week 12 was significantly greater (P < 0.001) for FP/FM (0.184 6 0.043 L) than FM alone (-0.004 6 0.041 L). Mean change (6 SE) in FEV1 from pre-dose at baseline to 2-hours post-dose at week 12 was significantly greater (P 5 0.006) for FP/FM (0.357 6 0.040 L) than FP alone (0.211 6 0.039 L). Reports of adverse events were low and similar across all treatment groups. CONCLUSIONS: Combination FP/FM was a more effective treatment for asthma than monotherapy with either FP or FM in patients with moderate to severe asthma.
601
Probiotics as an Adjunctive Treatment in Allergic Diseases of Respiratory Tract: A Systematic Review of Benefits and Risks R. R. Das, M. Singh, N. Gupta, N. Shafiq; PGIMER, Chandigarh, India. RATIONALE: A recent meta-analysis of randomized trials showed insufficient evidence to support use of probiotics in prevention of respiratory allergy. We conducted a systematic review on role of probiotics as an adjunctive treatment in respiratory allergy. METHODS: A systematic search of published literature was done. Randomized Controlled Trials (RCTs) (quality score 3) of probiotics in treatment of respiratory allergy were included. A pre-defined set of outcome measures were assessed. Weighted mean difference (WMD) with 95%confidence interval (CI) was calculated using RevMan(version 4.2.10). RESULTS: After screening, 5 RCTs (Japan 5 3, Italy 5 1, Finland 5 1) spanning over 7 years including 423 subjects qualified for inclusion. Due to differences in the outcomes, the data could not be pooled for majority of the outcomes. Among studies on asthma, probiotic use led to a significant worsening in symptom and medication scores; -4.05(-5.21,-2.88) and 1.50(1.13,1.87) respectively. However, there was significant reduction in time free from an episode of asthma[0.80 (0.62,0.98)] without any significant effect on duration of an episode [-0.47(-1.47,0.53)]. Among studies on allergic rhinitis, one study reported statistically significant benefit in nasal symptom-medication score (WMD could not calculated due to paucity of data) and another reported decrease in annual number of rhinitis episode [-1.6(-3.15,-0.05)].In the same study combined time free from rhinitis and asthma was significantly improved with probiotic use [1.40(1.30,1.50)].Of the immunological parameters, there was significant reduction in IgE level, pooled WMD (95%CI) -25.06 (-48.42,-1.70). Side-effects (GI upset, cold) were not significant. CONCLUSIONS: The evidence on probiotics in treatment of respiratory allergy is limited.Large clinical trials with evaluation of clinically relevant outcomes are needed.
MONDAY
598