Purpose of the Study
Influenza virus infection is a cause of major morbidity each year, especially in patients with chronic disease such as asthma. Although current recommendations are to administer influenza vaccine to children and adults with asthma, compliance is suboptimal because of various reasons including fear that the vaccine itself may trigger an asthma exacerbation. The purpose of this study was to assess the safety of influenza vaccine in patients with asthma.
Study Population
Two hundred sixty-two patients (114 males and 148 females) ages 18 to 75 years with a history of asthma, defined as recurrent episodes of airway obstruction that resolved on treatment, and whose diagnosis had been made by a clinical specialist.
Participants were randomly assigned to receive in a double-blind, crossover design, either the vaccine or placebo separated by 2 weeks. The primary clinical outcome measure was an asthma exacerbation within 72 hours of injection, defined by a decline in early - am peak expiratory flow (PEF) of more than 20% compared with the lowest of the best three early morning PEF values during the 3 days before the injection. Secondary outcome measures were: changes in upper/lower respiratory symptoms, systemic symptoms, and inhaled β2-agonist use 72 hours before and after injection; antibiotic and oral steroid therapy use 7 days after injection; and unscheduled medical consultations and hospital admissions for an exacerbation within 7 days of each injection.
No comments:
Post a Comment