Journal
RESPIRATORY MEDICINE
Volume 205, Issue -, Pages -Publisher
W B SAUNDERS CO LTD
DOI: 10.1016/j.rmed.2022.107040
Keywords
Single-inhaler triple therapy; Smoking; Lung function; Health-related quality of life; Symptoms
Funding
- GSK
- National Institute for Health Research (NIHR) Manchester Biomedical Research Centre (BRC)
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This study suggests that triple therapy (FF/UMEC/VI) can improve clinical outcomes in COPD patients regardless of smoking status compared to dual therapy. In former smokers, FF/UMEC/VI showed greater benefits compared to UMEC/VI, potentially due to relative corticosteroid resistance in current smokers.
Background: Smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). In IMPACT, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy significantly reduced moderate/severe exacerbation rates and improved lung function and health status versus FF/VI or UMEC/VI in COPD patients. This post hoc analysis investigated trial outcomes by smoking status. Methods: IMPACT was a double-blind, 52-week trial. Patients aged >= 40 years with symptomatic COPD and >= 1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. Endpoints assessed by smoking status at screening included rate and risk of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score at Week 52. Safety was also assessed. Results: Of the 10,355 patients in the intent-to-treat population, 3,587 (35%) were current smokers. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in current (rate ratio 0.85 [95% confidence interval: 0.77-0.95]; P = 0.003 and 0.86 [0.76-0.98]; P = 0.021) and former smokers (0.85 [0.78-0.91]; P < 0.001 and 0.70 [0.64-0.77]; P < 0.001). FF/UMEC/VI significantly reduced time-to-first on-treatment moderate/severe exacerbation versus FF/VI and UMEC/VI in former smokers, and versus FF/VI in current smokers. Similar trends were seen for lung function and health status. Former smokers receiving inhaled corticosteroid-containing therapy had higher pneumonia incidence than current smokers. Conclusions: FF/UMEC/VI improved clinical outcomes versus dual therapy regardless of smoking status. Benefits of FF/UMEC/VI versus UMEC/VI were greatest in former smokers, potentially due to relative corticosteroid resistance in current smokers.
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