Journal
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Volume 197, Issue 9, Pages 1136-1146Publisher
AMER THORACIC SOC
DOI: 10.1164/rccm.201709-1807OC
Keywords
treatment for COPD exacerbations; ICS; LABA
Categories
Funding
- Swiss National Foundation [PP00-P3_128412/1]
- Clinic of Pneumology of the University Hospital Basel
- Department of Biomedicine, University of Basel, Switzerland
- Astra AG
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Rationale: The efficacy of intensified combination therapy with inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABA) at the onset of upper respiratory tract infection (URTI) symptoms in chronic obstructive pulmonary disease (COPD) is unknown. Objectives: To evaluate whether intensified combination therapy with ICS/LABA, at the onset of URTI symptoms, decreases the incidence of COPD exacerbation occurring within 21 days of the URTI. Methods: A total of 450 patients with stable, moderate to very severe COPD, were included in this investigator-initiated and -driven, double-blind, randomized, placebo-controlled study. At inclusion, patients were assigned to open-labeled low-maintenance dose ICS/LABA. Each patient was randomized either to intensified-dose ICS/LABA or placebo and instructed to start using this medication only in case of a URTI, at the onset of symptoms, twice daily, for 10 days. Measurements and Main Results: The incidence of any exacerbation following a URTI was not significantly decreased in the ICS/LABA group, as compared with placebo (14.6% vs. 16.2%; hazard ratio, 0.77; 95% confidence interval, 0.46-1.33; P = 0.321) but the risk of severe exacerbation was decreased by 72% (hazard ratio, 0.28; 95% confidence interval, 0.11-0.74%; P = 0.010). In the stratified analysis, effect size was modified by disease severity, fractional exhaled nitric oxide, and the body mass index-airflow obstruction-dyspnea, and exercise score. Compared with the stable period, evidence of at least one virus was significantly more common at URTI, 10 days after URTI, and at exacerbation. Conclusions: Intensified combination therapy with ICS/LABA for 10 days at URTI onset did not decrease the incidence of any COPDexacerbation but prevented severe exacerbation. Patients with more severe disease had a significant risk reduction for any exacerbation.
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