J. Hedman et al., CONTROLLED TRIAL OF METHOTREXATE IN PATIENTS WITH SEVERE CHRONIC ASTHMA, European Journal of Clinical Pharmacology, 49(5), 1996, pp. 347-349
The aim of this study was to investigate the efficacy and adverse effe
cts of methotrexate (MTX) in the treatment of severe chronic asthma in
12 patients with severe asthma requiring continuous treatment with or
al steroids at the Outpatient Department of Helsinki University Centra
l Hospital. The study was a randomised, double-blind placebo-controlle
d trial of methotrexate treatment 15 mg weekly on a crossover basis ov
er 24 weeks. During the 2 weeks baseline phase the mean dose of oral s
teroids administered was 10.9 (3.2-28) mg . day(-1), and the mean dose
of inhaled steroids administered was 2.3 (1.6-3.2) mg budesonide or b
eclomethasone. The average dose of oral steroids administered was 12.8
mg . day(-1) during: the last 2 placebo weeks but only 7.9 mg . day(-
1) during the last 2 weeks with MTX treatment. The reduction in daily
dose of oral steroids was 38%, while daily bronchodilator use was redu
ced by 22%. During MTX treatment the patients experienced significantl
y less wheezing, dyspnoea and coughing. Nine out of 12 patients report
ed better asthma control during MTX treatment, The peak expiratory flo
w rate (PEF) 1-s forced expiratory volume (FEV(1)) values did not diff
er between MTX and placebo treatments, There was no statistical correl
ation between serum MTX concentration and clinical improvement, No ser
ious adverse effects of MTX were found during the study, It was conclu
ded that low-dose MTX may be beneficial for severe chronic asthma and
that this therapy is well tolerated by patients.