1/28/2024 0 Comments Captain ftp free trial![]() These results were supported by the analysis of clinic FEV 1 at 3 h post-dose. Baseline demographics were generally similar across all treatment groups. In the intention-to-treat population, 922 (38%) patients were men, the mean age was 53♲ years (SD 13♱) and body-mass index was 29♴ (6♶). Exploratory analyses of biomarkers of type 2 airway inflammation on treatment response were also done. Change from baseline in Evaluating Respiratory Symptoms in Asthma total score at weeks 21-24 was also a secondary endpoint but is not reported here. Other secondary endpoints were change from baseline in clinic FEV 1 at 3 h post-dose, St George's Respiratory Questionnaire (SGRQ) total score, and ACQ-7 total score, all at week 24. Endpoints assessed in the intention-to-treat population were change from baseline in clinic trough FEV 1 at week 24 (primary) and annualised moderate and/or severe asthma exacerbation rate (key secondary). ![]() Patients, investigators, and the funder were masked to treatment allocation. Participants were randomly assigned (1:1:1:1:1:1), via central based randomisation stratified by pre-study ICS dose at study entry, to once-daily FF/VI (100/25 μg or 200/25 μg) or FF/UMEC/VI (100/31♲5/25 μg, 100/62♵/25 μg, 200/31♲5/25 μg, or 200/62♵/25 μg) administered via Ellipta dry powder inhaler (Glaxo Operations UK, Hertfordshire, UK). Participants were eligible if they were aged 18 years or older, with inadequately controlled asthma (Asthma Control Questionnaire -6 score of ≥1♵) despite ICS/LABA, a documented health-care contact or a documented temporary change in asthma therapy for treatment of acute asthma symptoms in the year before screening, pre-bronchodilator FEV 1 between 30% and less than 85% of predicted normal value, and reversibility (defined as an increase in FEV 1 of ≥12% and ≥200 mL in the 20-60 min after four inhalations of albuterol or salbutamol) at screening. In this double-blind, randomised, parallel-group, phase 3A study (Clinical Study in Asthma Patients Receiving Triple Therapy in a Single Inhaler ), participants were recruited from 416 hospitals and primary care centres across 15 countries. We investigated the safety and efficacy of single-inhaler fluticasone furoate plus umeclidinium plus vilanterol (FF/UMEC/VI) compared with FF/VI. Electronic address: inhaled corticosteroid plus long-acting β 2-agonist (ICS/LABA) therapy, 30-50% of patients with moderate or severe asthma remain inadequately controlled. 12 Nuffield Department of Medicine and Oxford Respiratory NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.Electronic address: 1 GlaxoSmithKline (GSK), Collegeville, PA, USA. 11 Ghent University Hospital, Ghent, Belgium. ![]()
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