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Reduction of Nocturnal Awakenings With Mometasone Furoate Administered Via Dry Powder Inhaler in Children With Persistent Asthma Previously Receiving Other Inhaled Corticosteroids
Abstracts AB159
J ALLERGY CLIN IMMUNOL VOLUME 127, NUMBER 2
Reduction of Nocturnal Awakenings With Mometasone Furoate Administered Via Dry Powder Inhaler in Children With Persistent Asthma Previously Receiving Other Inhaled Corticosteroids W. E. Berger1, M. Noonan2, A. Teper3, J. Moreno-Cantu4, P. Stryszak3, E. O. Meltzer5; 1Allergy & Asthma Associates, Mission Viejo, CA, 2Allergy Associates Research, Portland, OR, 3Merck Research Laboratories, Kenilworth, NJ, 4Global Publications and Medical Communications, Merck & Co., Kenilworth, NJ, 5Allergy and Asthma Medical Group and Research Center, San Diego, CA. RATIONALE: The incidence of asthma-related nocturnal awakenings is an important measure of asthma control. The effect of mometasone furoate administered via dry powder inhaler (MF-DPI) on nocturnal awakenings was investigated post hoc using data from three pediatric trials. METHODS: Nocturnal awakening data from 3 phase III, randomized, double-blind, 12-week, placebo-controlled trials of MF-DPI (C97-300, C97-380, P01431) were analyzed post hoc for 902 children aged 4-11y with mild persistent asthma. Children were generally well controlled on other inhaled corticosteroids at recommended doses and switched to MF-DPI at baseline. Pooled treatment groups were MF-DPI 100mg/d (once-daily in the evening [QD PM, approved dose] or morning [QD AM]; n5279), MF-DPI 200mg/d (QD AM or 100mg twice-daily; n5351), and placebo (n5272). The Cochran-Mantel-Haenszel method was used to compare weekly nocturnal awakenings at endpoint relative to baseline in subjects on MF-DPI and placebo. RESULTS: Overall, 21% of subjects (192/902) had some nocturnal awakenings at baseline. Of these subjects, 90% (52/58) in the MF-DPI 100mg/d group and 81% (56/69) in the MF-DPI 200mg/d group had no increase in awakenings (relative to baseline) compared with 60% (39/65) of subjects on placebo (P<0.0016). Of subjects who had no nocturnal awakenings at baseline, 91% (201/221) in the MF-DPI 100mg/d group and 87% (244/ 282) in the MF-DPI 200mg/d group had no increase in awakenings at endpoint (relative to baseline) compared with 80% (165/207) of those on placebo (P<0.0016). CONCLUSION: Children with mild persistent asthma that was generally well controlled at baseline had reduced awakenings with MF-DPI compared with placebo.
604
Inhaler Use and Effect on Asthma Control N. Parikh1, P. Verma2, S. Lee2, W. B. Klaustermeyer2; 1UCLA Medical Center, Los Angeles, CA, 2VA Greater Los Angeles Healthcare System/UCLA Allergy-Immunology Division, Los Angeles, CA. RATIONALE: To examine patients’ knowledge and confidence in their use of inhalers and its relation to asthma control. METHODS: As part of an ongoing professional quality performance program, patients in our clinic with asthma voluntarily completed an anonymous survey and the Asthma Control Test (ACT). Two sample t-tests were used to analyze these data. RESULTS: Eighty-five patient surveys were included in this study. Mean age of patients was 63 years old. Knowing the names of the inhalers (p<0.01), knowing which are for quick relief (p<0.01), and knowing which are for long term control (p<0.01) were all significantly associated with higher patient confidence in use of their inhalers. Patient confidence was significantly associated with using inhalers as prescribed (p<0.01). Using inhalers as prescribed was significantly associated with higher ACT scores (p50.049). CONCLUSIONS: Our study shows that patients’ overall confidence in using inhalers is related to knowledge of their medications. This confidence translates into using inhalers as directed and in turn to higher ACT scores.
605
Impact of Inhaled Corticosteroids on Small Airway Airflow Obstruction in Asthmatic Children N. A. Sharif, E. Sarid, J. Li, J. Fagin; NorthShore-Long Island Jewish Health System, Great Neck, NY. RATIONALE: Forced expiratory flow between 25 and 75% of vital capacity (FEF 25-75) is a measure of small airway airflow obstruction. Asthmatic children may have impaired FEF 25-75 as the sole spirometric abnormality. The clinical benefits of inhaled corticosteroids (ICS) in relieving small airway airflow obstruction in asthmatic children have been difficult to assess. METHODS: This was a retrospective chart review of all patients ages 418 with diagnoses of asthma or wheezing seen in our Allergy and Pulmonary Clinics in 2009. Inclusion criteria included FEF 25-75 < _ 80% predicted, at least one follow-up visit > _4 80% predicted, FEV1 > weeks after the reference visit and either initiation or increased dose of ICS between visits. RESULTS: We reviewed 925 charts of asthmatic patients seen in our clinics. 154 patients (17%) qualified for inclusion, of which 97 (63%) initially were not on ICS and 57 (37%) were on low-dose ICS. The median FEF 25-75 was 64.7% predicted at the reference visit and 80.0% predicted at the subsequent visit with a percent change of 24.17% (p <0.0001). Median values for FVC were 103.9% and 106% (1.94% change, p<0.001), 88.8% and 97.5% for FEV1 (8.76% change, p<0.0001) and 87.4% and 95% for PEF (8% change, p<0.0001). Symptoms of cough, wheeze and/or chest tightness all decreased between visits. CONCLUSIONS: Initiation of ICS treatment or increase in ICS dose can significantly reverse small airway obstruction as well as improve symptomatic control in asthmatic children. This study underlines the importance of targeting small airways in the management of childhood asthma.
606
Effects of Low Dose combination therapy, Fluticasone Propionate/Salmeterol Combination, 100/50 (FSC 100/50) on Exhaled Nitric Oxide (eNO) and Airway Hyperresponsiveness in Mild Persistent Asthma M. A. Pasha, P. J. Feustel, T. Smith, S. Patel, S. Sarathchandra, P. Malone, M. Evans, F. Jourd’heuil, D. Jourd’heuil; Albany Medical College, Albany, NY. RATIONALE: Exhaled nitric oxide (eNO) has been proposed as a non-invasive marker of asthmatic airway inflammation. The aim of this study was to investigate the relationship between eNO and airway hyperresponsiveness and whether a combination of an inhaled corticosteroid and a long acting beta 2 agonist impacts on these variables. We measured changes in these markers, in addition to lung function, following four weeks of FSC 100/50 treatment. METHODS: In this open label study, 18 mild persistent, steroid-na€ıve asthmatics (age 22-62 years, FEV-1 > 70% predicted, PD20 <10mg/mL) were treated with FSC 100/50 1 inhalation BID, for 4 weeks. PD20 to methacholine, FEV-1 and eNO was measured, before and after 4 week of therapy. RESULTS: After four weeks of therapy with FSC 100/50, eNO fell from 74 (SD537) ppb to 34 (6 15) ppb (p<0.001). FEV-1 (% predicted) went up from 89 (611) to 93% (610) predicted (P<0.01). The PD20 for methacholine rose from 3.0 (6 3.2) to 10.3 (6 8.4) mg/mL (p<0.01) with 3 of 18 patients reaching the maximum allowable dose (25 mg/mL). The increase in PD20 dose with the therapy was .13 (SD5.20) mg/mL, for each percentage decrease in eNO. CONCLUSION: These results suggest that treatment of mild persistent steroid-na€ıve asthmatics with low dose combination therapy is effective in reducing airway inflammation (eNO) and airway hyperreactivity. There was a statistically significant correlation between the methacholine dose and eNO.
MONDAY
603
J ALLERGY CLIN IMMUNOL VOLUME 127, NUMBER 2
Reduction of Nocturnal Awakenings With Mometasone Furoate Administered Via Dry Powder Inhaler in Children With Persistent Asthma Previously Receiving Other Inhaled Corticosteroids W. E. Berger1, M. Noonan2, A. Teper3, J. Moreno-Cantu4, P. Stryszak3, E. O. Meltzer5; 1Allergy & Asthma Associates, Mission Viejo, CA, 2Allergy Associates Research, Portland, OR, 3Merck Research Laboratories, Kenilworth, NJ, 4Global Publications and Medical Communications, Merck & Co., Kenilworth, NJ, 5Allergy and Asthma Medical Group and Research Center, San Diego, CA. RATIONALE: The incidence of asthma-related nocturnal awakenings is an important measure of asthma control. The effect of mometasone furoate administered via dry powder inhaler (MF-DPI) on nocturnal awakenings was investigated post hoc using data from three pediatric trials. METHODS: Nocturnal awakening data from 3 phase III, randomized, double-blind, 12-week, placebo-controlled trials of MF-DPI (C97-300, C97-380, P01431) were analyzed post hoc for 902 children aged 4-11y with mild persistent asthma. Children were generally well controlled on other inhaled corticosteroids at recommended doses and switched to MF-DPI at baseline. Pooled treatment groups were MF-DPI 100mg/d (once-daily in the evening [QD PM, approved dose] or morning [QD AM]; n5279), MF-DPI 200mg/d (QD AM or 100mg twice-daily; n5351), and placebo (n5272). The Cochran-Mantel-Haenszel method was used to compare weekly nocturnal awakenings at endpoint relative to baseline in subjects on MF-DPI and placebo. RESULTS: Overall, 21% of subjects (192/902) had some nocturnal awakenings at baseline. Of these subjects, 90% (52/58) in the MF-DPI 100mg/d group and 81% (56/69) in the MF-DPI 200mg/d group had no increase in awakenings (relative to baseline) compared with 60% (39/65) of subjects on placebo (P<0.0016). Of subjects who had no nocturnal awakenings at baseline, 91% (201/221) in the MF-DPI 100mg/d group and 87% (244/ 282) in the MF-DPI 200mg/d group had no increase in awakenings at endpoint (relative to baseline) compared with 80% (165/207) of those on placebo (P<0.0016). CONCLUSION: Children with mild persistent asthma that was generally well controlled at baseline had reduced awakenings with MF-DPI compared with placebo.
604
Inhaler Use and Effect on Asthma Control N. Parikh1, P. Verma2, S. Lee2, W. B. Klaustermeyer2; 1UCLA Medical Center, Los Angeles, CA, 2VA Greater Los Angeles Healthcare System/UCLA Allergy-Immunology Division, Los Angeles, CA. RATIONALE: To examine patients’ knowledge and confidence in their use of inhalers and its relation to asthma control. METHODS: As part of an ongoing professional quality performance program, patients in our clinic with asthma voluntarily completed an anonymous survey and the Asthma Control Test (ACT). Two sample t-tests were used to analyze these data. RESULTS: Eighty-five patient surveys were included in this study. Mean age of patients was 63 years old. Knowing the names of the inhalers (p<0.01), knowing which are for quick relief (p<0.01), and knowing which are for long term control (p<0.01) were all significantly associated with higher patient confidence in use of their inhalers. Patient confidence was significantly associated with using inhalers as prescribed (p<0.01). Using inhalers as prescribed was significantly associated with higher ACT scores (p50.049). CONCLUSIONS: Our study shows that patients’ overall confidence in using inhalers is related to knowledge of their medications. This confidence translates into using inhalers as directed and in turn to higher ACT scores.
605
Impact of Inhaled Corticosteroids on Small Airway Airflow Obstruction in Asthmatic Children N. A. Sharif, E. Sarid, J. Li, J. Fagin; NorthShore-Long Island Jewish Health System, Great Neck, NY. RATIONALE: Forced expiratory flow between 25 and 75% of vital capacity (FEF 25-75) is a measure of small airway airflow obstruction. Asthmatic children may have impaired FEF 25-75 as the sole spirometric abnormality. The clinical benefits of inhaled corticosteroids (ICS) in relieving small airway airflow obstruction in asthmatic children have been difficult to assess. METHODS: This was a retrospective chart review of all patients ages 418 with diagnoses of asthma or wheezing seen in our Allergy and Pulmonary Clinics in 2009. Inclusion criteria included FEF 25-75 < _ 80% predicted, at least one follow-up visit > _4 80% predicted, FEV1 > weeks after the reference visit and either initiation or increased dose of ICS between visits. RESULTS: We reviewed 925 charts of asthmatic patients seen in our clinics. 154 patients (17%) qualified for inclusion, of which 97 (63%) initially were not on ICS and 57 (37%) were on low-dose ICS. The median FEF 25-75 was 64.7% predicted at the reference visit and 80.0% predicted at the subsequent visit with a percent change of 24.17% (p <0.0001). Median values for FVC were 103.9% and 106% (1.94% change, p<0.001), 88.8% and 97.5% for FEV1 (8.76% change, p<0.0001) and 87.4% and 95% for PEF (8% change, p<0.0001). Symptoms of cough, wheeze and/or chest tightness all decreased between visits. CONCLUSIONS: Initiation of ICS treatment or increase in ICS dose can significantly reverse small airway obstruction as well as improve symptomatic control in asthmatic children. This study underlines the importance of targeting small airways in the management of childhood asthma.
606
Effects of Low Dose combination therapy, Fluticasone Propionate/Salmeterol Combination, 100/50 (FSC 100/50) on Exhaled Nitric Oxide (eNO) and Airway Hyperresponsiveness in Mild Persistent Asthma M. A. Pasha, P. J. Feustel, T. Smith, S. Patel, S. Sarathchandra, P. Malone, M. Evans, F. Jourd’heuil, D. Jourd’heuil; Albany Medical College, Albany, NY. RATIONALE: Exhaled nitric oxide (eNO) has been proposed as a non-invasive marker of asthmatic airway inflammation. The aim of this study was to investigate the relationship between eNO and airway hyperresponsiveness and whether a combination of an inhaled corticosteroid and a long acting beta 2 agonist impacts on these variables. We measured changes in these markers, in addition to lung function, following four weeks of FSC 100/50 treatment. METHODS: In this open label study, 18 mild persistent, steroid-na€ıve asthmatics (age 22-62 years, FEV-1 > 70% predicted, PD20 <10mg/mL) were treated with FSC 100/50 1 inhalation BID, for 4 weeks. PD20 to methacholine, FEV-1 and eNO was measured, before and after 4 week of therapy. RESULTS: After four weeks of therapy with FSC 100/50, eNO fell from 74 (SD537) ppb to 34 (6 15) ppb (p<0.001). FEV-1 (% predicted) went up from 89 (611) to 93% (610) predicted (P<0.01). The PD20 for methacholine rose from 3.0 (6 3.2) to 10.3 (6 8.4) mg/mL (p<0.01) with 3 of 18 patients reaching the maximum allowable dose (25 mg/mL). The increase in PD20 dose with the therapy was .13 (SD5.20) mg/mL, for each percentage decrease in eNO. CONCLUSION: These results suggest that treatment of mild persistent steroid-na€ıve asthmatics with low dose combination therapy is effective in reducing airway inflammation (eNO) and airway hyperreactivity. There was a statistically significant correlation between the methacholine dose and eNO.
MONDAY
603