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- Title
Effects of Inhaled Corticosteroid/Long-Acting β<sub>2</sub>-Agonist Combination on the Airway Microbiome of Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Clinical Trial (DISARM).
- Authors
Leitao Filho, Fernando Sergio; Hiroto Takiguchi; Kentaro Akata; Seung Won Ra; Ji-Yong Moon; Hyun Kuk Kim; Yuji Cho; Kei Yamasaki; Milne, Stephen; Yang, Julia; Cheng Wei Tony Yang; Xuan Li; Nislow, Corey; van Eeden, Stephan F.; Shaipanich, Tawimas; Lam, Stephen; Leung, Janice M.; Sin, Don D.; Takiguchi, Hiroto; Akata, Kentaro
- Abstract
Rationale: Inhaled corticosteroids (ICS) are commonly prescribed with long-acting β2-agonists (LABA) in chronic obstructive pulmonary disease (COPD). To date, the effects of ICS therapy on the airway microbiome in COPD are unknown. Objectives: To determine the effects of ICS/LABA on the airway microbiome of patients with COPD. Methods: Clinically stable patients with COPD were enrolled into a 4-week run-in period during which ICS was discontinued and all participants were placed on formoterol (Form) 12 μg twice daily (BID). The participants were then randomized to budesonide/formoterol (Bud + Form; 400/12 μg BID), fluticasone/salmeterol (Flu + Salm; 250/50 μg BID), or formoterol only (12 μg BID) for 12 weeks. Participants underwent bronchoscopy before and after the 12-week treatment period. The primary endpoint was the comparison of changes in the airway microbiome over the trial period between the ICS/LABA and LABA-only groups. Measurements and Main Results: Sixty-three participants underwent randomization: Bud + Form (n = 20), Flu + Salm (n = 22), and Form (n = 21) groups; 56 subjects completed all visits. After the treatment period, changes in α-diversity were significantly different across groups, especially between Flu + Salm and Form groups (Δrichness: P = 0.02; ΔShannon index: P = 0.03). Longitudinal differential abundance analyses revealed more pronounced microbial shifts from baseline in the fluticasone (vs. budesonide or formoterol only) group. Conclusions: Fluticasone-based ICS/LABA therapy modifies the airway microbiome in COPD, leading to a relative reduction in α-diversity and a greater number of bacterial taxa changes. These data may have implications in patients who develop pneumonia on ICS. Clinical trial registered with www.clinicaltrials.gov (NCT02833480).
- Subjects
CORTICOSTEROIDS; OBSTRUCTIVE lung disease treatment; RANDOMIZED controlled trials; COMBINATION drug therapy; BRONCHOSCOPY; FORMOTEROL; ADRENERGIC beta agonists; RESEARCH; ADRENOCORTICAL hormones; RESEARCH methodology; CELL receptors; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; OBSTRUCTIVE lung diseases; RESEARCH funding; INHALATION administration; STATISTICAL sampling
- Publication
American Journal of Respiratory & Critical Care Medicine, 2021, Vol 204, Issue 10, p1143
- ISSN
1073-449X
- Publication type
journal article
- DOI
10.1164/rccm.202102-0289OC