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The Efficacy and Safety of Beclomethasone Dipropionate Delivered via a Breath-Actuated Inhaler in Adult and Adolescent Patients With Persistent Asthma
AB96 Abstracts
302
Tiotropium Respimat® 2.5 mg Add-on to ICS or ICS+controller medications Improves Lung Function in Adults and Adolescents With Mild, Moderate, or Severe Symptomatic Asthma
SUNDAY
William E. Berger, MD, MBA1, Eli O. Meltzer, MD, FAAAAI2, Anna Unseld3, Asif Shaikh4, and Michael Engel5; 1Southern California Research Center, Mission Viejo, 2Allergy and Asthma Medical Group & Research Center, San Diego, CA, 3Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, 4Clinical Development and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. RATIONALE: To investigate lung function in adults and adolescents (12– 17 years old) taking tiotropium Respimat®(TioR) 2.5 mg plus ICS or ICS+controller medications. _3 months METHODS: Patients with mild, moderate, or severe asthma (> asthma history; pre-bronchodilator FEV1 60–90% of predicted normal); added once-daily TioR (2.5 mg or 5mg [2.5mg reported only]) in the evening or placebo Respimat® (pboR) to ICS or ICS+controller medications in 5 phase III RCTs. In 4 trials, patients received TioR/placebo plus ICS: GraziaTinA-asthma® (NCT01316380; 12 weeks; n5464 adults; mild (NCT01172808/ asthma), 2 replicate MezzoTinA-asthma® NCT01172821; 24 weeks; n52100 adults; moderate asthma), and RubaTinA-asthma® (NCT01257230; 48 weeks; n5397 adolescents; moderate asthma). In 1 trial patients received TioR/placebo plus ICS+controller medications: PensieTinA-asthma® (NCT01277523; 12 weeks; n5392 ad_800-mg budeolescents; severe asthma). ICS doses ranged from 200- to > sonide or equivalent. All trials permitted LTRAs (except GraziaTinAasthma®). Primary or secondary endpoints included change from baseline in peak FEV1(0-3h) (response) and trough FEV1. RESULTS: Overall, 925 patients received TioR 2.5 mg, and 951 received pboR. TioR 2.5 mg plus ICS significantly improved peak FEV1(0-3h) response over placebo (GraziaTinA-asthma®: 159 mL, P<0.0001; 2 replicate Mezzo TinA-asthma® pooled: 223 mL, P<0.0001; RubaTinAasthma®: 134 mL, P50.009). Similarly, TioR 2.5 mg plus ICS+controller medications improved peak FEV1(0-3h) response (PensieTinA-asthma®: 111 mL, P50.046). Differences with placebo in trough FEV1response were 110 mL (P50.003), 180 mL (P<0.0001), 84 mL (P50.131), and 115 mL (P50.051), respectively. Adverse events were similar between groups. CONCLUSIONS: TioR 2.5 mg plus ICS or ICS+controller medications improved lung function in adults and adolescents with asthma.
303
Perception of oral corticosteroid side effects in patients with corticosteroid-dependent asthma
Charlene M. Prazma, PhD1, Sally E. Wenzel, MD, FAAAAI2, Linda M. Nelsen3, Necdet B. Gunsoy4, Sarah M. Cockle5, Frank C. Albers1, Hector Ortega, MD, FAAAAI5, and Steven W. Yancey, MS1; 1GSK, Research Triangle Park, NC, 2University of Pittsburgh Medical Center NW, Pittsburgh, PA, 3GSK, Collegeville, PA, 4GSK, Uxbridge, United Kingdom, 5GSK, Brentford, United Kingdom. RATIONALE: Corticosteroid-dependent patients are concerned with drug-related complications associated with long term oral corticosteroid (OCS) treatment. We characterize the adverse events (AEs) reported by severe asthma patients using at least 5mg/day of prednisone equivalent. METHODS: At baseline corticosteroid-dependent asthmatics (N5135) in the SIRIUS study (GSK:NCT01691508) completed the Steroid Perception Questionnaire to assess their experience and perception of the AEs associated with daily OCS use. Patient perception of AEs was rated on a 5 point scale (05not at all worried, 5 5 extremely worried) and baseline results were summarized. RESULTS: The median baseline OCS dose was 12.8mg/day with 48% _5 years. The majority of patients (n565) of patients using OCS for >
J ALLERGY CLIN IMMUNOL FEBRUARY 2017
(n5112,84%) reported concern about AEs associated with OCS use. Specifically, 73% (n598) reported experiencing weight gain, 41% experienced trouble sleeping (n555) and 41% experienced thinning of skin/ stretch marks (n555). Patients were most concerned about future risk of eye problem/cataracts (n565, 48%), weight gain (n565,48%), and fragile bones (n564,47%), with the majority of patients taking additional preventative medications (71%, n595). CONCLUSIONS: Patients describe a high prevalence of OCS complications with daily OCS use including those impacting daily experiences such as trouble sleeping and weight gain. While weight gain occurs most frequently and is worrisome, patients reported being as or more worried about the chronic and irreversible impact to their eyes and bones. These concerns can have a negative impact on medication adherence and subsequently asthma control. Physician’s knowledge of patients’ concerns can help lead to treatment decisions that could mitigate patient concerns with OCS use.
304
The Efficacy and Safety of Beclomethasone Dipropionate Delivered via a Breath-Actuated Inhaler in Adult and Adolescent Patients With Persistent Asthma
Nancy K. Ostrom, MD, CPI1, Gordon Raphael, MD2, Jeffrey Tillinghast, MD, CPI3, Lisa Hickey, MS4, and Calvin Small, MD, MS4; 1 Allergy and Asthma Medical Group & Research Center, San Diego, CA, 2Bethesda Allergy, Asthma and Research Center, Bethesda, MD, 3 The Clinical Research Center, St. Louis, MT, 4Teva Pharmaceuticals, Frazer, PA. RATIONALE: Efficacy and safety of beclomethasone dipropionate (BDP) administered via breath-actuated inhaler (BAI) versus placebo was evaluated in asthmatic patients. METHODS: This phase 3, 6-week, double-blind study (NCT02513160) _12 years). During a 14- to included patients with persistent asthma (aged > 30-day single-blind run-in, patients discontinued asthma medications and received albuterol metered-dose inhaler (MDI) for rescue and twice-daily placebo BAI or MDI for training. At randomization, BAI patients received BDP BAI 320 mcg/day, BDP BAI 640 mcg/day, or placebo BAI. MDI patients were randomized to receive BDP MDI 320 mcg/day or placebo MDI. Standardized baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve from 0 to 6 weeks (FEV1AUEC0–6wk; primary), morning peak expiratory flow (PEF), rescue medication use, asthma symptoms, withdrawals, and tolerability were assessed. RESULTS: The modified intent-to-treat and safety populations each included 425 patients. BDP BAI 320 and 640 mcg/day significantly improved FEV1AUEC0–6wk versus placebo (P<0.0001). Active BAI treatment groups exhibited significantly improved morning PEF, rescue medi_0.0003). Similar cation use, and asthma symptoms versus placebo (P< _0.0006). Fewer patreatment effects were demonstrated for BDP MDI (P< tients withdrew due to worsening asthma while taking BDP BAI 320 mcg/ day (n51), BDP BAI 640 mcg/day (n50), and BDP MDI 320 mcg/day (n51) versus placebo (n510). BDP BAI was safe and well tolerated. CONCLUSIONS: BDP BAI demonstrated significant improvements in lung function and symptom control versus placebo with similar results for BDP MDI. BDP BAI’s safety profile was comparable to BDP MDI, with no new safety signals. Funding: Teva Pharmaceuticals.
302
Tiotropium Respimat® 2.5 mg Add-on to ICS or ICS+controller medications Improves Lung Function in Adults and Adolescents With Mild, Moderate, or Severe Symptomatic Asthma
SUNDAY
William E. Berger, MD, MBA1, Eli O. Meltzer, MD, FAAAAI2, Anna Unseld3, Asif Shaikh4, and Michael Engel5; 1Southern California Research Center, Mission Viejo, 2Allergy and Asthma Medical Group & Research Center, San Diego, CA, 3Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, 4Clinical Development and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. RATIONALE: To investigate lung function in adults and adolescents (12– 17 years old) taking tiotropium Respimat®(TioR) 2.5 mg plus ICS or ICS+controller medications. _3 months METHODS: Patients with mild, moderate, or severe asthma (> asthma history; pre-bronchodilator FEV1 60–90% of predicted normal); added once-daily TioR (2.5 mg or 5mg [2.5mg reported only]) in the evening or placebo Respimat® (pboR) to ICS or ICS+controller medications in 5 phase III RCTs. In 4 trials, patients received TioR/placebo plus ICS: GraziaTinA-asthma® (NCT01316380; 12 weeks; n5464 adults; mild (NCT01172808/ asthma), 2 replicate MezzoTinA-asthma® NCT01172821; 24 weeks; n52100 adults; moderate asthma), and RubaTinA-asthma® (NCT01257230; 48 weeks; n5397 adolescents; moderate asthma). In 1 trial patients received TioR/placebo plus ICS+controller medications: PensieTinA-asthma® (NCT01277523; 12 weeks; n5392 ad_800-mg budeolescents; severe asthma). ICS doses ranged from 200- to > sonide or equivalent. All trials permitted LTRAs (except GraziaTinAasthma®). Primary or secondary endpoints included change from baseline in peak FEV1(0-3h) (response) and trough FEV1. RESULTS: Overall, 925 patients received TioR 2.5 mg, and 951 received pboR. TioR 2.5 mg plus ICS significantly improved peak FEV1(0-3h) response over placebo (GraziaTinA-asthma®: 159 mL, P<0.0001; 2 replicate Mezzo TinA-asthma® pooled: 223 mL, P<0.0001; RubaTinAasthma®: 134 mL, P50.009). Similarly, TioR 2.5 mg plus ICS+controller medications improved peak FEV1(0-3h) response (PensieTinA-asthma®: 111 mL, P50.046). Differences with placebo in trough FEV1response were 110 mL (P50.003), 180 mL (P<0.0001), 84 mL (P50.131), and 115 mL (P50.051), respectively. Adverse events were similar between groups. CONCLUSIONS: TioR 2.5 mg plus ICS or ICS+controller medications improved lung function in adults and adolescents with asthma.
303
Perception of oral corticosteroid side effects in patients with corticosteroid-dependent asthma
Charlene M. Prazma, PhD1, Sally E. Wenzel, MD, FAAAAI2, Linda M. Nelsen3, Necdet B. Gunsoy4, Sarah M. Cockle5, Frank C. Albers1, Hector Ortega, MD, FAAAAI5, and Steven W. Yancey, MS1; 1GSK, Research Triangle Park, NC, 2University of Pittsburgh Medical Center NW, Pittsburgh, PA, 3GSK, Collegeville, PA, 4GSK, Uxbridge, United Kingdom, 5GSK, Brentford, United Kingdom. RATIONALE: Corticosteroid-dependent patients are concerned with drug-related complications associated with long term oral corticosteroid (OCS) treatment. We characterize the adverse events (AEs) reported by severe asthma patients using at least 5mg/day of prednisone equivalent. METHODS: At baseline corticosteroid-dependent asthmatics (N5135) in the SIRIUS study (GSK:NCT01691508) completed the Steroid Perception Questionnaire to assess their experience and perception of the AEs associated with daily OCS use. Patient perception of AEs was rated on a 5 point scale (05not at all worried, 5 5 extremely worried) and baseline results were summarized. RESULTS: The median baseline OCS dose was 12.8mg/day with 48% _5 years. The majority of patients (n565) of patients using OCS for >
J ALLERGY CLIN IMMUNOL FEBRUARY 2017
(n5112,84%) reported concern about AEs associated with OCS use. Specifically, 73% (n598) reported experiencing weight gain, 41% experienced trouble sleeping (n555) and 41% experienced thinning of skin/ stretch marks (n555). Patients were most concerned about future risk of eye problem/cataracts (n565, 48%), weight gain (n565,48%), and fragile bones (n564,47%), with the majority of patients taking additional preventative medications (71%, n595). CONCLUSIONS: Patients describe a high prevalence of OCS complications with daily OCS use including those impacting daily experiences such as trouble sleeping and weight gain. While weight gain occurs most frequently and is worrisome, patients reported being as or more worried about the chronic and irreversible impact to their eyes and bones. These concerns can have a negative impact on medication adherence and subsequently asthma control. Physician’s knowledge of patients’ concerns can help lead to treatment decisions that could mitigate patient concerns with OCS use.
304
The Efficacy and Safety of Beclomethasone Dipropionate Delivered via a Breath-Actuated Inhaler in Adult and Adolescent Patients With Persistent Asthma
Nancy K. Ostrom, MD, CPI1, Gordon Raphael, MD2, Jeffrey Tillinghast, MD, CPI3, Lisa Hickey, MS4, and Calvin Small, MD, MS4; 1 Allergy and Asthma Medical Group & Research Center, San Diego, CA, 2Bethesda Allergy, Asthma and Research Center, Bethesda, MD, 3 The Clinical Research Center, St. Louis, MT, 4Teva Pharmaceuticals, Frazer, PA. RATIONALE: Efficacy and safety of beclomethasone dipropionate (BDP) administered via breath-actuated inhaler (BAI) versus placebo was evaluated in asthmatic patients. METHODS: This phase 3, 6-week, double-blind study (NCT02513160) _12 years). During a 14- to included patients with persistent asthma (aged > 30-day single-blind run-in, patients discontinued asthma medications and received albuterol metered-dose inhaler (MDI) for rescue and twice-daily placebo BAI or MDI for training. At randomization, BAI patients received BDP BAI 320 mcg/day, BDP BAI 640 mcg/day, or placebo BAI. MDI patients were randomized to receive BDP MDI 320 mcg/day or placebo MDI. Standardized baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve from 0 to 6 weeks (FEV1AUEC0–6wk; primary), morning peak expiratory flow (PEF), rescue medication use, asthma symptoms, withdrawals, and tolerability were assessed. RESULTS: The modified intent-to-treat and safety populations each included 425 patients. BDP BAI 320 and 640 mcg/day significantly improved FEV1AUEC0–6wk versus placebo (P<0.0001). Active BAI treatment groups exhibited significantly improved morning PEF, rescue medi_0.0003). Similar cation use, and asthma symptoms versus placebo (P< _0.0006). Fewer patreatment effects were demonstrated for BDP MDI (P< tients withdrew due to worsening asthma while taking BDP BAI 320 mcg/ day (n51), BDP BAI 640 mcg/day (n50), and BDP MDI 320 mcg/day (n51) versus placebo (n510). BDP BAI was safe and well tolerated. CONCLUSIONS: BDP BAI demonstrated significant improvements in lung function and symptom control versus placebo with similar results for BDP MDI. BDP BAI’s safety profile was comparable to BDP MDI, with no new safety signals. Funding: Teva Pharmaceuticals.