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• W4387249938 abstract "SESSION TITLE: Asthma Treatment and Longitudinal Studies SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/09/2023 12:00 pm - 12:45 pm PURPOSE: Albuterol–budesonide is a rescue treatment for asthma that combines in a single pressurized metered dose inhaler a short-acting β2‑agonist, for bronchodilation and rapid symptom relief, with an inhaled corticosteroid (ICS) to concomitantly treat worsening inflammation that underlies symptoms which may lead to an exacerbation. In the Phase 3 MANDALA study (NCT03769090), as-needed albuterol–budesonide 180/160 µg significantly reduced the risk of a severe exacerbations by 27% vs albuterol in patients ≥12 years with moderate-to-severe asthma receiving ICS-containing maintenance therapy and who had ≥1 severe exacerbation in the past year. Patient-reported adherence to maintenance medication was high (median, 85% of days). Here we report lung function data from the MANDALA study. METHODS: In MANDALA, patients ≥12 years (FEV1 ≥40–<90% predicted normal, ≥12% reversibility) were randomized 1:1:1 to as-needed albuterol–budesonide 180/160 μg, albuterol–budesonide 180/80 μg or albuterol 180 μg. Patients remained on their own ICS-containing maintenance medication throughout. Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 24 was analyzed (repeated measures analysis) as an exploratory endpoint, and the proportions of patients with FEV1 improvements from baseline to Week 24 ≥100 mL, ≥150 mL, or ≥12% were assessed post hoc. Data are reported for albuterol–budesonide 180/160 µg (FDA-approved dose) and albuterol. RESULTS: Baseline mean (SD) pre-bronchodilator FEV1 was 2.0 (0.7) L for both groups (albuterol–budesonide 180/160 µg, n=1013; as-needed albuterol, n=1014). The estimated least square mean (LSM) [SE] increase in pre-bronchodilator FEV1 from baseline to Week 24 was 134.3 [20.2] mL in the albuterol–budesonide 180/160 µg group and 74.0 [20.3] mL in the albuterol group (LSM difference, 60.3 mL [95% CI, 27.8, 92.8]). At Week 24, a numerically greater proportion of patients in the albuterol–budesonide 180/160 µg group than in the albuterol group had improvements from baseline in pre-bronchodilator FEV1 ≥100 mL (46% vs 38%), ≥150 mL (38% vs 31%), and ≥12% (29% vs 24%). CONCLUSIONS: Lung function improvements were observed in a population of patients with high adherence to their background ICS-containing maintenance medication. Patients receiving as-needed albuterol–budesonide experienced greater improvements in pre-bronchodilator FEV1 than those receiving as-needed albuterol. CLINICAL IMPLICATIONS: Lower lung function is a risk for exacerbations in patients with asthma; the reduction in the risk of severe exacerbations observed in MANDALA with the albuterol–budesonide rescue inhaler may in part be due to improved lung function. Study funding: Bond Avillion 2 Development LP. Medical writing funding: AstraZeneca. DISCLOSURES: Employee relationship with Avillion LLP Please note: since 06 /03 /2019 Added 04 /03 /2023 by Frank Albers, source=Web Response, value=Salary Scientific medical adviser relationship with AstraZeneca Please note: 24 months by Richard Beasley, value=Honoraria Scientific Medical Advisor relationship with Avillion Please note: 24 months by Richard Beasley, value=Consulting fee Scientific Medical Advisor relationship with Teva Please note: 2022/23 Added 04/02/2023 by Richard Beasley, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with Teva Please note: 2022/23 Added 04/02/2023 by Richard Beasley, source=Web Response, value=Consulting fee Removed 04/03/2023 by Richard Beasley, source=Web Response Employee relationship with AstraZeneca Please note: July 2000 Added 04/04/2023 by Christy Cappelletti, source=Web Response, value=hold stock Speaker/Speaker's Bureau relationship with Sanofi Genzyme Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Boeringer Ingelheim Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Removed 03/31/2023 by Bradley Chipps, source=Web Response Speaker/Speaker's Bureau relationship with Genentech Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Consultant relationship with GlaxoSmithKline Please note: $5001 - $20000 by Bradley Chipps, value=Consulting fee Removed 03/31/2023 by Bradley Chipps, source=Web Response Speaker/Speaker's Bureau relationship with Novartis Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Regeneron Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria No relevant relationships by Anna Danilewicz Employee relationship with AstraZeneca Please note: 01/05/2019 Added 04/03/2023 by Lynn Dunsire, source=Web Response, value=Shareholder Employee relationship with AstraZeneca Please note: >$100000 by Ileen Gilbert, value=Salary Stock relationship with AstraZeneca Please note: $20001 - $100000 by Ileen Gilbert, value=Stock My spouse/partner as a Consultant relationship with Abott Please note: $20001 - $100000 by Ileen Gilbert, value=Consulting fee Removed 03/30/2023 by Ileen Gilbert, source=Web Response Employee relationship with AstraZeneca Please note: Ongoing by Ileen Gilbert, value=Salary Employee relationship with AstraZeneca Please note: 2020-present Added 04/06/2023 by Tim Harrison, source=Web Response, value=Salary Consultant relationship with Sanofi Genzyme Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Consulting fee non financial support relationship with Sanofi-Regeneron Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Glaxo Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with CSL Behring Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Nestle Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Om Pharmaceuticals Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Laurel Pharmaceuticals Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Sun Pharmaceuticals Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with TEVA Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Genentech Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support non financial support relationship with Circassia Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=non financial support Clinical Research grant relationship with AstraZeneca Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical Research grant relationship with Avillion Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical Research grant relationship with Circassia Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Grant/Research Support Consultant relationship with AstraZeneca Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Regeneron Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Consulting fee Stock owner relationship with Nesos Corp Please note: In past 2 years Added 04/04/2023 by Elliot Israel, source=Web Response, value=Stock Options;unpaid No relevant relationships by Allison Jeynes-Ellis Advisory Committee Member relationship with Theravance Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Merck & Co Please note: 24 months by Reynold Panettieri, value=Honoraria Consultant relationship with Bayer Please note: 24 months by Reynold Panettieri, value=Honoraria Contracted Research relationship with Evelobio Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Contracted Research relationship with Johnson & Johnson Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Research grant recipient relationship with Theravance Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Advisory Committee Member relationship with Avillion Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 11/30/2022 by Reynold Panettieri, source=Web Response Principal Investigator relationship with OncoArendi Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Consultant relationship with AstraZeneca Please note: 24 months by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with AstraZeneca Please note: 24 months by Reynold Panettieri, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: 24 months by Reynold Panettieri, value=Honoraria Principal Investigator relationship with AstraZeneca Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Consultant relationship with RIFM Please note: 24 months by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with RIFM Please note: 24 months by Reynold Panettieri, value=Honoraria Principal Investigator relationship with RIFM Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Genentech Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Contracted Research relationship with AgoMab Please note: 24 months Added 11/30/2022 by Reynold Panettieri, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Sanofi Please note: 24 months by Reynold Panettieri, value=Honoraria Principal Investigator relationship with Vault Health Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Janssen Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with ACTIV-1 Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Origo Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 04/03/2023 by Reynold Panettieri, source=Web Response Principal Investigator relationship with Medimmune Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Novartis Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Equillium Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with TEVA Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 11/30/2022 by Reynold Panettieri, source=Web Response Consultant relationship with TEVA Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 11/30/2022 by Reynold Panettieri, source=Web Response Advisory Committee Member relationship with Genentech Please note: 24 months by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with CHIESI, AZ, GSK, MSD, NOVARTIS, SANOFI, AVILLION, ELPEN Please note: 24 months Added 03/31/2023 by Alberto Papi, source=Web Response, value=Consulting fee Removed 03/31/2023 by Alberto Papi, source=Web Response Scientific Medical Advisor relationship with CHIESI, AZ, GSK, MSD, NOVARTIS, SANOFI, AVILLION, Helpen Please note: 24 months Added 03/31/2023 by Alberto Papi, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with CHIESI, ASTRAZENECA, GSK, MENARINI, NOVARTIS, ZAMBON Please note: 24 months Added 03/31/2023 by Alberto Papi, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with MUNDIPHARMA, SANOFI, AVILLION, Please note: 24 months Added 03/31/2023 by Alberto Papi, source=Web Response, value=Honoraria Shareholder relationship with AstraZeneca Please note: >5 years by Frank Trudo, value=Shares" @default.
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• W4387249938 date "2023-10-01" @default.
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• W4387249938 title "ALBUTEROL–BUDESONIDE AS-NEEDED RESCUE IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA IMPROVED LUNG FUNCTION OVER 24 WEEKS VS ALBUTEROL ALONE IN THE MANDALA STUDY" @default.
• W4387249938 doi "https://doi.org/10.1016/j.chest.2023.07.101" @default.
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