ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Phase III Evaluation of the Efficacy and Safety of PT027 (Budesonide/Albuterol pMDI) Compared to Placebo pMDI on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects with Asthma: the TYREE Study
Session Title
D7 - D007 ADVANCES IN ASTHMA THERAPIES
Abstract
A1200 - Phase III Evaluation of the Efficacy and Safety of PT027 (Budesonide/Albuterol pMDI) Compared to Placebo pMDI on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects with Asthma: the TYREE Study
Author Block: C. F. Laforce1, B. E. Chipps2, F. C. Albers3, L. Reilly4, E. Johnsson5, H. Andrews3, C. Cappelletti6, A. Maes5, A. Papi7; 1North Carolina Clinical Research, Raleigh, NC, United States, 2Capital Allergy & Respiratory Disease Center, Sacramento, CA, United States, 3Avillion US Inc., Northbrook, IL, United States, 4Avillion LLP, London, United Kingdom, 5BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 6BioPharmaceuticals R&D, AstraZeneca, Durham, NC, United States, 7University of Ferrara, Ferrara, Italy.
Rationale: Short-acting beta2-agonists (SABAs) such as albuterol provide rapid relief of asthma symptoms and reduce or prevent exercise-induced bronchoconstriction (EIB). Recent GINA guidelines recommend adding low-dose inhaled corticosteroid (ICS) to a fast-acting bronchodilator as rescue medication as early as GINA Step 1 asthma. PT027 is a fixed dose combination of budesonide and albuterol in a single pressurized metered dose inhaler (pMDI). PT027 is currently in clinical development as an anti-inflammatory rescue/reliever for asthma; these are the first study results. Here, PT027 efficacy and safety was evaluated in subjects with asthma and EIB. Methods: TYREE (NCT04234464) was a randomized, double-blind, single-dose, crossover study to assess the preventative effects of PT027 (2 puffs 80/90µg MDI) compared with placebo pMDI (2 puffs) on EIB in subjects with asthma. Adults and adolescents (≥12 years) with asthma and EIB receiving SABA as needed (prn) alone or in addition to low-to-medium-dose ICS maintenance therapy were enrolled. EIB was defined by a ≥20% decrease from 5-minute pre-exercise challenge test (ECT) best forced expiratory volume in 1 second (FEV1) observed within 60 minutes after ECT. The primary endpoint was maximum percentage fall from post-dose, pre-exercise baseline FEV1 observed up to 60 minutes post-ECT. Secondary and exploratory endpoints included percentage of subjects with a maximum percentage post-ECT fall in FEV1 of <10% (full protection) and <20% (partial protection). Safety endpoints were assessed as adverse events (AEs) and serious AEs (SAEs). Results: The study included 60 subjects (mean age 40.5 years, 63% female, mean % predicted FEV1 5-min pre-ECT at Screening 83%) and met its primary endpoint with LS mean maximum percentage falls from baseline in FEV1 of 5.45% vs 18.97% for PT027 and placebo, respectively, with a difference of -13.52% (95% CI -16.94, -10.09, p<0.001). The proportion of fully and partially protected subjects, respectively, was 78.3% vs 28.3% and 90.0% vs 51.7% for PT027 vs placebo, with odds ratios of 10.5 (p<0.001) and 10.8 (p<0.001). Similar results were also seen in subgroup analyses of subjects receiving SABA prn only and maintenance ICS plus SABA prn. PT027 was well tolerated. Conclusions: The TYREE study demonstrated efficacy of PT027 to prevent EIB in subjects with asthma, including subjects receiving SABA prn alone or maintenance ICS plus SABA prn, when compared to placebo. These results provide important information towards the evaluation of PT027 as a potential new anti-inflammatory rescue/reliever therapy for subjects with asthma. Sponsor: Avillion
Author Block: C. F. Laforce1, B. E. Chipps2, F. C. Albers3, L. Reilly4, E. Johnsson5, H. Andrews3, C. Cappelletti6, A. Maes5, A. Papi7; 1North Carolina Clinical Research, Raleigh, NC, United States, 2Capital Allergy & Respiratory Disease Center, Sacramento, CA, United States, 3Avillion US Inc., Northbrook, IL, United States, 4Avillion LLP, London, United Kingdom, 5BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 6BioPharmaceuticals R&D, AstraZeneca, Durham, NC, United States, 7University of Ferrara, Ferrara, Italy.
Rationale: Short-acting beta2-agonists (SABAs) such as albuterol provide rapid relief of asthma symptoms and reduce or prevent exercise-induced bronchoconstriction (EIB). Recent GINA guidelines recommend adding low-dose inhaled corticosteroid (ICS) to a fast-acting bronchodilator as rescue medication as early as GINA Step 1 asthma. PT027 is a fixed dose combination of budesonide and albuterol in a single pressurized metered dose inhaler (pMDI). PT027 is currently in clinical development as an anti-inflammatory rescue/reliever for asthma; these are the first study results. Here, PT027 efficacy and safety was evaluated in subjects with asthma and EIB. Methods: TYREE (NCT04234464) was a randomized, double-blind, single-dose, crossover study to assess the preventative effects of PT027 (2 puffs 80/90µg MDI) compared with placebo pMDI (2 puffs) on EIB in subjects with asthma. Adults and adolescents (≥12 years) with asthma and EIB receiving SABA as needed (prn) alone or in addition to low-to-medium-dose ICS maintenance therapy were enrolled. EIB was defined by a ≥20% decrease from 5-minute pre-exercise challenge test (ECT) best forced expiratory volume in 1 second (FEV1) observed within 60 minutes after ECT. The primary endpoint was maximum percentage fall from post-dose, pre-exercise baseline FEV1 observed up to 60 minutes post-ECT. Secondary and exploratory endpoints included percentage of subjects with a maximum percentage post-ECT fall in FEV1 of <10% (full protection) and <20% (partial protection). Safety endpoints were assessed as adverse events (AEs) and serious AEs (SAEs). Results: The study included 60 subjects (mean age 40.5 years, 63% female, mean % predicted FEV1 5-min pre-ECT at Screening 83%) and met its primary endpoint with LS mean maximum percentage falls from baseline in FEV1 of 5.45% vs 18.97% for PT027 and placebo, respectively, with a difference of -13.52% (95% CI -16.94, -10.09, p<0.001). The proportion of fully and partially protected subjects, respectively, was 78.3% vs 28.3% and 90.0% vs 51.7% for PT027 vs placebo, with odds ratios of 10.5 (p<0.001) and 10.8 (p<0.001). Similar results were also seen in subgroup analyses of subjects receiving SABA prn only and maintenance ICS plus SABA prn. PT027 was well tolerated. Conclusions: The TYREE study demonstrated efficacy of PT027 to prevent EIB in subjects with asthma, including subjects receiving SABA prn alone or maintenance ICS plus SABA prn, when compared to placebo. These results provide important information towards the evaluation of PT027 as a potential new anti-inflammatory rescue/reliever therapy for subjects with asthma. Sponsor: Avillion
