Majid Mirsadraee - Internist and pulmonologist, Academic Professor, Islamic Azad University- Mashhad Branch, Mashhad, Iran
Sanaz Dehghan - Innovative Research Center, Faculty of Medicine, Islamic Azad University, Mashhad Branch, Mashhad, Iran
Shadi Ghaffari - MSc in Biology, Research Department, Kavosh High School, Mashhad, Iran
Niloofar Mirsadraee - MSc in Cell and Molecular Biology, Innovative Research Center, Faculty of Medicine, Islamic Azad University, Mashhad Branch, Mashhad, Iran

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 ۱۱۰ therapy-resistant asthmatic patients who were randomly assigned into two groups of case and control. The patients in the case group were administered ۲۰۰ mg itraconazole twice a day and the control group received ۱۰ mg prednisolone after breakfast for ۴ 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 ۱-۴, with ۱ representing no symptom and ۴ indicating severe exhausting disturbance. Results: Based on the obtained results, ۷۱% 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 ۶۰% 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: ۱۴ before the trial and >۲۰ after the trial) and spirometry parameters underwent a considerable change from obstructive pattern to normal. Furthermore, adverse effects were only detected in ۶% 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.

Anti-fungal therapy, Asthma, Fungal sensitization, itraconazole, Resistant asthma, Triazole