Study objective: To determine if treatment with inhaled budesonide forte can diminish increased bronchial hyperreactivity and improve symptoms in patients with mitral valve stenosis.
Design: The study was randomized, double blind, and placebo controlled.
Setting: Outpatient/university hospital.
Patients: Twelve subjects, 8 female and 4 male, who qualified for mitral valve replacement. All subjects presented with increased bronchial reactivity to histamine at the time of the study.
Interventions: Patients received placebo or budesonide forte twice a day (1,200 mg/d) for 6 weeks. During the study, patients were treated with the same doses of diuretics and other medications that could affect bronchial reactivity.
Measurements: Spirometry, provocative concentration of histamine causing a 20% fall in the FEV1 (PC20H), symptom scores.
Results: In the treated group, the initial PC20H was 0.82 ± 0.72 mg/mL; in the placebo group 1.39 ± 1.3 mg/mL. After 6 weeks of treatment, PC20H was significantly higher (3.07 ± 2.28 mg/mL; p > 0.01) in the budesonide-treated group and remained unchanged in the placebo group (1.49 ± 0.91). Symptom scores were significantly lower after administration of budesonide forte (mean change, 4.0 ± 2.6).
Conclusions: Six weeks of treatment with budesonide forte significantly decreased bronchial reactivity to histamine and improved symptoms in patients with mitral valve stenosis.