The clinical trial of Fevipiprant, conducted by experts at Leicester University, found that it led to a big drop in the the symptoms of asthma, improved sufferers’ lung function, reduced inflammation of the lungs and also helped to repair the lining of patients’ airways.
Background
Eosinophilic airway
inflammation is often present in asthma, and reduction of such
inflammation results in improved clinical outcomes. We hypothesised that
fevipiprant (QAW039), an antagonist of prostaglandin D2 receptor 2, might reduce eosinophilic airway inflammation in patients with moderate-to-severe eosinophilic asthma.
Methods
We
performed a single-centre, randomised, double-blind, parallel-group,
placebo-controlled trial at Glenfield Hospital (Leicester, UK). We
recruited patients with persistent, moderate-to-severe asthma and an
elevated sputum eosinophil count (≥2%). After a 2-week single-blind
placebo run-in period, patients were randomly assigned (1:1) by the
trial pharmacist, using previously generated treatment allocation cards,
to receive fevipiprant (225 mg twice per day orally) or placebo,
stratified by the use of oral corticosteroid treatment and bronchoscopy.
The 12-week treatment period was followed by a 6-week single-blind
placebo washout period. The primary outcome was the change in sputum
eosinophil percentage from baseline to 12 weeks after treatment,
analysed in the intention-to-treat population. All patients who received
at least one dose of study drug were included in the safety analyses.
This trial is registered with ClinicalTrials.gov, number NCT01545726, and with EudraCT, number 2011-004966-13.
Findings
Between
Feb 10, 2012, and Jan 30, 2013, 61 patients were randomly assigned to
receive fevipiprant (n=30) or placebo (n=31). Three patients in the
fevipiprant group and four patients in the placebo group withdrew
because of asthma exacerbations. Two patients in the fevipiprant group
were incorrectly given placebo (one at the mid-treatment visit and one
throughout the course of the study). They were both included in the
fevipiprant group for the primary analysis, but the patient who was
incorrectly given placebo throughout was included in the placebo group
for the safety analyses. Between baseline and 12 weeks after treatment,
sputum eosinophil percentage decreased from a geometric mean of 5·4%
(95% CI 3·1–9·6) to 1·1% (0·7–1·9) in the fevipiprant group and from
4·6% (2·5–8·7) to 3·9% (CI 2·3–6·7) in the placebo group. Compared with
baseline, mean sputum eosinophil percentage was reduced by 4·5 times in
the fevipiprant group and by 1·3 times in the placebo group (difference
between groups 3·5 times, 95% CI 1·7–7·0; p=0·0014). Fevipiprant had a
favourable safety profile, with no deaths or serious adverse events
reported. No patient withdrawals were judged by the investigator to be
related to the study drug.
Interpretation
Fevipiprant
reduces eosinophilic airway inflammation and is well tolerated in
patients with persistent moderate-to-severe asthma and raised sputum
eosinophil counts despite inhaled corticosteroid treatment.
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