Background Despite current recommendations, many people with asthma do not receive annual vaccination against influenza, partly because of concern that vaccine may trigger exacerbations.
Colds can trigger exacerbations, which may be mistaken for vaccine-related adverse events.
We undertook a double-blind placebo-controlled multicentre crossover study to assess the safety of influenza vaccine in patients with asthma, with allowance for the occurrence of colds.
Methods We studied 262 patients, aged 18-75 years, who recorded daily peak expiratory flow (PEF), respiratory symptoms, medication, medical consultations, and hospital admissions for 2 weeks before the first injection and until 2 weeks after the second injection.
Order of injection (vaccine and placebo) was assigned randomly.
There was an interval of 2 weeks between injections.
The main outcome measure was an exacerbation of asthma within 72 h of injection (defined as a fall in PEF of>20%). Findings Among 255 participants with paired data, 11 recorded a fall in PEF of more than 20% after vaccine compared with three after placebo (McNemar's test p=0.06) ; a fall of more than 30% was recorded by eight after vaccine compared with none after placebo (binomial test p=0.008).
However, when participants with colds were excluded, there was no significant difference in the numbers with falls of more than 20% between vaccine and placebo (six vs three ; binomial test p=0. (...)
Mots-clés Pascal : Asthme, Randomisation, Etude double insu, Grippe, Virose, Infection, Vaccination, Facteur sécurité, Essai thérapeutique contrôlé, Etude multicentrique, Homme, Appareil respiratoire pathologie, Bronchopneumopathie obstructive, Prévention
Mots-clés Pascal anglais : Asthma, Randomization, Double blind study, Influenza, Viral disease, Infection, Vaccination, Safety factor, Controlled therapeutic trial, Multicenter study, Human, Respiratory disease, Obstructive pulmonary disease, Prevention
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0103284
Code Inist : 002B05A02. Création : 22/06/1998.