Intensified Therapy with Inhaled Corticosteroids and LABA at the Onset of URTI to Prevent COPD Exacerbations- A Multicentre, Randomised, Double-blind, Placebo-controlled Trial.

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Abstract

RATIONAL

The efficacy of intensified combination therapy with inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) at the onset of upper respiratory tract infection (URTI) symptoms in 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

450 patients with stable, moderate to very severe COPD, were included in this investigator-initiated and driven, double-blind, randomised, placebo-controlled study. At inclusion, patients were assigned to open-labelled low maintenance dose ICS/LABA. Each patient was randomised either to intensified dose ICS/LABA or placebo and instructed to start using this medication only in case of an 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 to placebo (14.6% versus 16.2%, HR 0.77, 95%CI 0.46-1.33, P=.321) but the risk of severe exacerbation was decreased by 72% (HR 0.28, 95%CI 0.11-0.74%, P=.010). In the stratified analysis, effect size was modified by disease severity, FeNO and BODE score. Compared to 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 COPD exacerbation but prevented severe exacerbation. Patients with more severe disease had a significant risk reduction for any exacerbation. Clinical trial registration available at http://www.isrctn.com, ID ISRCTN45572998.

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