- Email: [email protected]
Evaluation of Efficacy of Flunisolide HFA (AEROSPAN) in Children 4 to 11 Years of Age: A Sub-Group Efficacy Analysis By Baseline Asthma Medication Use
15
Effect of Fixed Airflow Obstruction (FAO) Status on Lung Function, Asthma Control Days (ACD), and Asthma Symptom Score (AS) Responses to Budesonide/Formoterol (BUD/FM) Treatment in Patients with Moderate-to-Severe Asthma Donald P. Tashkin, MD1, Frank Trudo, MD2, Michael DePietro, MD2, Bradley E. Chipps, MD, FAAAAI3; 1David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, 2AstraZeneca LP, Wilmington, DE, 3Capital Allergy & Respiratory Disease Center, Sacramento, CA. RATIONALE: Assess FAO status effect on FEV1 and asthma symptoms in response to BUD/FM in moderate-to-severe asthma patients. METHODS: This post-hoc analysis assessed patients randomized to bid BUD/FM pMDI 320/9mg, BUD pMDI 320mg, FM DPI 9mg, or placebo (PBO) (NCT00652002) for FAO status postbronchodilator at screening and post-study-drug at weeks 2, 6, and 12, via FEV1/FVC tients had inconsistent FAO status among visits. Mean AS response, % pa_100mL and % ACD are tients with mean change from baseline in FEV1 > reported. RESULTS: Percentages of patients with changes in predose FEV1 _100mL for BUD/FM vs BUD, FM, and PBO were: FAO+ (75% [n532] > vs 40.7% [n527], 23.5% [n534], and 16.7% [n530]), FAO variable (57.1% [n528] vs 46.9% [n532], 29.7% [n537], and 8.8% [n534]), and FAO2 (59.6% [n547] vs 47.1% [n534], 70.4% [n527], and 48.1% [n527]). AS change was greater for BUD/FM vs BUD, FM, and PBO patients for FAO+ (20.21 vs 20.14, 20.08, and 20.07), FAO variable (20.30 vs 20.13, 20.10, and 0.01), and FAO– (20.33 vs 20.19, 20.21, and 20.07). Percentage ACD improved most with BUD/FM vs BUD, FM, and PBO patients for FAO+ (17.0% vs 2.2%, 6.5%, and 1.7%), FAO variable (14.5% vs 3.1%, 7.5%, and 3.3%), and FAO– (21.8% vs 14.5%, 2.8%, and 3.7%). CONCLUSIONS: BUD/FM appeared to show greater lung function improvement compared with BUD and FM for FAO+ and FAO variable patients and greater symptom improvements compared with BUD and FM regardless of FAO status. Supported by AstraZeneca.
16
Evaluation of Efficacy of Flunisolide HFA (AEROSPAN) in Children 4 to 11 Years of Age: A Sub-Group Efficacy Analysis By Baseline Asthma Medication Use John Karafilidis, PharmD, Nancy Ruiz, MD, Alison G. Martens, BS, RN; Meda Pharmaceuticals, Somerset, NJ. RATIONALE: A 12-week, multicenter, placebo- and active-controlled trial in pediatric patients 4 to 11 years (n5513) with mild-to-moderate asthma was conducted, where 80 mcg and 160 mcg BID doses of flunisolide HFA were compared to 250 mcg and 500 mcg BID doses of flunisolide CFC. Post-hoc analyses were performed to evaluate the effect of flunisolide HFA by baseline asthma medication, either an inhaled corticosteroid [ICS] or antileukotriene agents. METHODS: Sub-groups were analyzed for the primary endpoint (change from baseline to 12 weeks of treatment in % predicted FEV1). The most commonly used ICSs prior to study entry were: beclomethasone (n5129; mean daily dose of 236.7 mcg); fluticasone (n569; mean daily dose of 325.3 mcg) and triamcinolone (n552; mean daily dose of 445.5 mcg). Antileukotrines were montelukast and zafirlukast (n538). RESULTS: Patients treated with flunisolide HFA, following a 2-week runin with flunisolide CFC 500mcg BID, had % predicted FEV1 values that improved over their previous ICS. Respective mean improvements in % predicted FEV1 were: 7.6% (160 mcg) to 4.8% (80 mcg) for the beclomethasone subgroup; 2.9% (80 mcg) to 6.3% (160 mcg) for the fluticasone subgroup; and 13.6% (80 mcg) to 8.0% (160 mcg) for the triamcinolone subgroup. In addition, patients treated with antileukotrienes
had a 7.7% (80 mcg) to 14.7% (160 mcg) improvement in % predicted FEV1. CONCLUSIONS: After 12 weeks of treatment, pediatric patients 4 to 11 years treated with flunisolide HFA (80 and 160 mcg BID) had meaningful improvements in efficacy as assessed by % predicted FEV1, regardless of their previous ICS.
17
Level of Asthma Control in Children after Subcutaneous Immunotherapy Maria Isabel Garcimartin, MD1, Francisco Javier Ruano2, Diana Perez Alzate3, Natalia Blanca-Lopez, MD, PhD1, Maria Luisa Somoza, MD1, Maria Vazquez De La Torre, MD4, Ana Anton-Laiseca, MD5, Maria Gabriela Canto Diez5; 1Allergy Unit. Infanta Leonor University Hospital, Madrid, Spain, 2Allergy Unit. Infanta Leonor University Hospital. Hospital Infanta Leonor, Madrid, Spain, 3HU Infanta Leonor, 4 HU INFANTA LEONOR, Madrid, Spain, 5HU INFANTA LEONOR. RATIONALE: Asthma control (AC) is to which patient’s symptoms are reduced by the treatment. Our objective was to investigate the level of AC after treatment with grass pollen subcutaneous immunotherapy (SCIT) in children with seasonal allergic asthma. METHODS: 105 patients (45 female, 60 male, age 5 to 14 years) with asthma due to grass pollen were included from 2010 to 2014. Allergy was confirmed by clinical history, skin prick test and serum specific IgE. Asthma severity was assessed according to GINA guidelines Patients received SCIT in a cluster schedule. The level of AC was evaluated in the first and third pollen seasons after SCIT initiation through a questionnaire of symptoms, limitation of activities, night symptoms and use of rescue medication in the last 4 weeks. Asthma was then classified into well, partly controlled and uncontrolled. RESULTS: From the group 28.1 %patients had intermittent; 48.3 % mild persistent and 23.6 % moderate persistent asthma. In the first pollen season 35.8%of children had well controlled asthma, 51% not well and 13.2 % an uncontrolled asthma. In the third pollen season 70.5% of patients had well controlled asthma, 23.6 % not well- and 6.7 % an uncontrolled asthma. The absence of AC resulted equally in all groups of asthma severity, but greater AC was achieved in those with moderate asthma. CONCLUSIONS: SCIT with grass pollen allows AC in the first year of treatment; although a greater control is achieved after longer treatment. In addition we have observed that AC not depends on the severity of symptoms.
SATURDAY
Abstracts AB5
J ALLERGY CLIN IMMUNOL VOLUME 135, NUMBER 2
Effect of Fixed Airflow Obstruction (FAO) Status on Lung Function, Asthma Control Days (ACD), and Asthma Symptom Score (AS) Responses to Budesonide/Formoterol (BUD/FM) Treatment in Patients with Moderate-to-Severe Asthma Donald P. Tashkin, MD1, Frank Trudo, MD2, Michael DePietro, MD2, Bradley E. Chipps, MD, FAAAAI3; 1David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, 2AstraZeneca LP, Wilmington, DE, 3Capital Allergy & Respiratory Disease Center, Sacramento, CA. RATIONALE: Assess FAO status effect on FEV1 and asthma symptoms in response to BUD/FM in moderate-to-severe asthma patients. METHODS: This post-hoc analysis assessed patients randomized to bid BUD/FM pMDI 320/9mg, BUD pMDI 320mg, FM DPI 9mg, or placebo (PBO) (NCT00652002) for FAO status postbronchodilator at screening and post-study-drug at weeks 2, 6, and 12, via FEV1/FVC
16
Evaluation of Efficacy of Flunisolide HFA (AEROSPAN) in Children 4 to 11 Years of Age: A Sub-Group Efficacy Analysis By Baseline Asthma Medication Use John Karafilidis, PharmD, Nancy Ruiz, MD, Alison G. Martens, BS, RN; Meda Pharmaceuticals, Somerset, NJ. RATIONALE: A 12-week, multicenter, placebo- and active-controlled trial in pediatric patients 4 to 11 years (n5513) with mild-to-moderate asthma was conducted, where 80 mcg and 160 mcg BID doses of flunisolide HFA were compared to 250 mcg and 500 mcg BID doses of flunisolide CFC. Post-hoc analyses were performed to evaluate the effect of flunisolide HFA by baseline asthma medication, either an inhaled corticosteroid [ICS] or antileukotriene agents. METHODS: Sub-groups were analyzed for the primary endpoint (change from baseline to 12 weeks of treatment in % predicted FEV1). The most commonly used ICSs prior to study entry were: beclomethasone (n5129; mean daily dose of 236.7 mcg); fluticasone (n569; mean daily dose of 325.3 mcg) and triamcinolone (n552; mean daily dose of 445.5 mcg). Antileukotrines were montelukast and zafirlukast (n538). RESULTS: Patients treated with flunisolide HFA, following a 2-week runin with flunisolide CFC 500mcg BID, had % predicted FEV1 values that improved over their previous ICS. Respective mean improvements in % predicted FEV1 were: 7.6% (160 mcg) to 4.8% (80 mcg) for the beclomethasone subgroup; 2.9% (80 mcg) to 6.3% (160 mcg) for the fluticasone subgroup; and 13.6% (80 mcg) to 8.0% (160 mcg) for the triamcinolone subgroup. In addition, patients treated with antileukotrienes
had a 7.7% (80 mcg) to 14.7% (160 mcg) improvement in % predicted FEV1. CONCLUSIONS: After 12 weeks of treatment, pediatric patients 4 to 11 years treated with flunisolide HFA (80 and 160 mcg BID) had meaningful improvements in efficacy as assessed by % predicted FEV1, regardless of their previous ICS.
17
Level of Asthma Control in Children after Subcutaneous Immunotherapy Maria Isabel Garcimartin, MD1, Francisco Javier Ruano2, Diana Perez Alzate3, Natalia Blanca-Lopez, MD, PhD1, Maria Luisa Somoza, MD1, Maria Vazquez De La Torre, MD4, Ana Anton-Laiseca, MD5, Maria Gabriela Canto Diez5; 1Allergy Unit. Infanta Leonor University Hospital, Madrid, Spain, 2Allergy Unit. Infanta Leonor University Hospital. Hospital Infanta Leonor, Madrid, Spain, 3HU Infanta Leonor, 4 HU INFANTA LEONOR, Madrid, Spain, 5HU INFANTA LEONOR. RATIONALE: Asthma control (AC) is to which patient’s symptoms are reduced by the treatment. Our objective was to investigate the level of AC after treatment with grass pollen subcutaneous immunotherapy (SCIT) in children with seasonal allergic asthma. METHODS: 105 patients (45 female, 60 male, age 5 to 14 years) with asthma due to grass pollen were included from 2010 to 2014. Allergy was confirmed by clinical history, skin prick test and serum specific IgE. Asthma severity was assessed according to GINA guidelines Patients received SCIT in a cluster schedule. The level of AC was evaluated in the first and third pollen seasons after SCIT initiation through a questionnaire of symptoms, limitation of activities, night symptoms and use of rescue medication in the last 4 weeks. Asthma was then classified into well, partly controlled and uncontrolled. RESULTS: From the group 28.1 %patients had intermittent; 48.3 % mild persistent and 23.6 % moderate persistent asthma. In the first pollen season 35.8%of children had well controlled asthma, 51% not well and 13.2 % an uncontrolled asthma. In the third pollen season 70.5% of patients had well controlled asthma, 23.6 % not well- and 6.7 % an uncontrolled asthma. The absence of AC resulted equally in all groups of asthma severity, but greater AC was achieved in those with moderate asthma. CONCLUSIONS: SCIT with grass pollen allows AC in the first year of treatment; although a greater control is achieved after longer treatment. In addition we have observed that AC not depends on the severity of symptoms.
SATURDAY
Abstracts AB5
J ALLERGY CLIN IMMUNOL VOLUME 135, NUMBER 2