CAPTAIN: EFFECTS OF AGE OF ASTHMA ONSET AS A CONTINUOUS VARIABLE ON TREATMENT OUTCOMES

TOPIC: Respiratory Care TYPE: Original Investigations PURPOSE: The CAPTAIN study showed that adding umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) led improvements in lung function and symptom control patients with uncontrolled asthma on inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). In a previous analysis of CAPTAIN, we response FF/UMEC/VI may vary according the age at which patient develops (<18 vs ≥18 years age). Here, further explore potential differential treatment responses using onset as continuous variable. METHODS: This Phase IIIA, double-blind, 24–52-week, parallel-group randomized adults despite ICS/LABA therapy (N=2436). Treatment: once-daily FF/VI (100/25, 200/25mcg) or (100/31.25/25, 100/62.5/25, 200/31.25/25, 200/62.5/25mcg) (ELLIPTA inhaler). Here report post hoc analyses change from baseline clinic trough forced expiratory volume 1 second (FEV1) Week 24 (analyzed mixed model repeated measures) annualized rate moderate/severe exacerbations (Weeks 1–52; analyzed negative binomial model) onset. Treatment groups were pooled by addition UMEC 62.5mcg FF dose. Fractional polynomial modelling was used effect each endpoint. RESULTS: Mean (SD) disease duration 32.0 (18.74) 21.2 (15.31) years, respectively. Greater FEV1 (~100mL) seen following across range ages developed. Addition appeared be more effective reducing exacerbation advancing onset, however there considerable overlap 95% confidence intervals. higher dose (200mcg) associated small numerical versus 100mcg irrespective although some Furthermore, less pronounced compared UMEC. also numerically greater reductions all uncertainty extremes due lower numbers patients. CONCLUSIONS: use generally outcomes independent except for among youngest where data. CLINICAL IMPLICATIONS: Improvements observed onset.Funding: GSK (205715/NCT02924688). DISCLOSURES: Employee relationship Please note: Aug 2017 - current Added 04/20/2021 Zelie Bailes, source=Web Response, value=Salary value=Ownership interest >$100000 Neil Barnes, value=Shares Participation multicenter clinical research trials AstraZeneca $20001 $100000 Louis-Philippe Boulet, source=Admin input, value=Grant/Research Support Advisory Committee Member $5001 $20000 value=Consulting fee Merck Novartis Takeda Fees consulting Metapharm re Boston Scientific Hoffman La Roche Ono Pharma Sanofi Boehringer Ingelheim Production educational material value=Non profit grants Boehringer-Ingelheim Non Covis 2014-2021 05/04/2021 Frances Gardiner, AstraZeneca, Genentech, GSK, Mylan, 2020-2021 Nicola Hanania, Consultant Regeneron, Amgen, Teva Research support Ingelheim, Genzyme Genentech Supportresearch grant Boehringer-Ingelheim, GlaxoSmithKline, Novartis, Sano one year 04/26/2021 Hiromasa Inoue, Speaker/Speaker's Bureau Kyorin, moment value=Honoraria Paul Jones, GlaxoSmithKLine $1001 $5000 Huib Kerstjens, Amphastar 2012-present Edward Kerwin, 2015 Cipla 2016 Chiesi 2018-present value=Travel GlaxoSmithKline 2014-present Mylan Sunovion Theravance 2015-2019 Connect Biopharma 2020-present Sanofi, >24 months Njira Lugogo, Removed Response TEVA Funds devleoping CME presentations AKH 04/19/2021 Clinical institution funding developing Greentech Regeneron trial AKH, Medscape NACE No relevant relationships Robert Nathan, 04/21/2021 Reynold Panettieri, RIFM Equillium Genetech Sanofi/Regeneron Bayer Contracted Optikira Medimmune Maven Evelobio Johnson & AstraZeneca; RIFM; Equillium; Genentech; Thervance 04/22/2021 Sanofi/Regeneron; recipient Novartis; Optikira; Medimmune; Maven; Johnson; Principal Investigator MedImmune Reseaerch Institute Fragrance Materials Avillion OncoArendi Metera January 04/27/2021 Emilio Pizzichini, David Slade, Former Astra Zeneca value=Stock