Benefits of low weekly doses of methotrexate in steroid-dependent asthmatic patients. A doubleblind, randomized, placebo-controlled study

Abstract

Background: Though several drugs have been tested, the choice of the ideal steroidsparing agent in steroid-dependent asthmatic patients remains unclear. Our objective was to evaluate the efficacy and tolerance of methotrexate in low weekly doses in order to decrease chronic oral steroid requirements in asthmatic patients. Methods: Design: double blind randomized placebo-controlled study. Setting: The study was performed in a 760-bed teaching hospital. Patients: 46 steroid-dependent asthmatic patients were randomized. Interventions: Patients received 10 mg of methotrexate or placebo once weekly for a year. The 6-methylprednisolone was progressively tapered (2 mg/day every two weeks) until FEV1 diminished by 5% or more; 6-methylprednisolone was then increased until the previous FEV1 was reached, and the procedure was repeated throughout follow-up. Measurements: Blood and urine analyses and bone densitometry were performed at entry and at the end of the study. Pulmonary function was tested monthly during the first three months and then every three months until the end.