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

Document Type : Original Articles


1 Internist and pulmonologist, Academic Professor, Islamic Azad University- Mashhad Branch, Mashhad, Iran

2 Innovative Research Center, Faculty of Medicine, Islamic Azad University, Mashhad Branch, Mashhad, Iran

3 MSc in Biology, Research Department, Kavosh High School, Mashhad, Iran

4 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 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.


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Volume 5, Issue 4
December 2019
Pages 1-7
  • Receive Date: 20 April 2019
  • Revise Date: 23 August 2019
  • Accept Date: 02 October 2019
  • First Publish Date: 01 December 2019