long-term effect of antifungal therapy for the treatment of severe resistant asthma: an active comparator clinical trial

Background and purpose: itraconazole therapy has been reported to control asthma in severe therapy-resistant asthma with fungal sensitization. the aim of this study was to investigate the impact of anti-fungal therapy on the treatment of severe asthma, irrespective of sensitization. materials and methods: this active comparator clinical trial was performed on 110 therapy-resistant asthmatic patients who were randomly assigned into two groups of case and control. the patients in the case group were administered 200 mg itraconazole twice a day and the control group received 10 mg prednisolone after breakfast for 4 months. the asthma control test (act) which was used as a marker for the global evaluation of treatment effectiveness (gete) was applied as the primary endpoint parameter. cough, dyspnea, and sleep disturbance were measured on a scale of 1-4, with 1 representing no symptom and 4 indicating severe exhausting disturbance. results: based on the obtained results, 71% of the itraconazole group demonstrated a marked improvement in the gete score after a four-month treatment. itraconazole was able to suppress clinical symptoms, including cough, dyspnea, and night symptoms, and their physical exam was indicative of normalization in 60% of the patients. on the other hand, the patients in the parallel group prednisolone were only able to control dyspnea. the act score represented a notable improvement with itraconazole (mean: 14 before the trial and >20 after the trial) and spirometry parameters underwent a considerable change from obstructive pattern to normal. furthermore, adverse effects were only detected in 6% of itraconazole users. conclusion: the results of this clinical trial indicted the effectiveness of antifungal therapy for the control of the clinical condition of a subgroup of patients with severe steroid-refractory asthma.