Itraconazole Improved Bronchial Wall thickness in Severe Persistent Asthma: A Double-blind Placebo-controlled Randomized Clinical Trial

Farnaz Aligolighasemabadi; Majid Mirsadraee; Mohammadamin Sadeghdoust; Shadi Ghaffari; Mohammad  Sarafraz Yazdi; Saeed Naghibi; Amirhossein  Hashemi Attar

doi:10.18502/ijaai.v22i1.12000

Farnaz Aligolighasemabadi Department of Internal Medicine, Mashhad Medical Sciences Branch, Islamic Azad University, Mashhad, Iran
Majid Mirsadraee Department of Internal Medicine, Medical School, Islamic Azad University, Mashhad Branch, Mashhad, Iran
Mohammadamin Sadeghdoust Department of Internal Medicine, Mashhad Medical Sciences Branch, Islamic Azad University, Mashhad, Iran
Shadi Ghaffari Department of Physiology, Faculty of Biology, Islamic Azad University, Damghan Branch, Damghan, Iran
Mohammad Sarafraz Yazdi Department of Internal Medicine, Mashhad Medical Sciences Branch, Islamic Azad University, Mashhad, Iran
Saeed Naghibi Department of Radiology, Mashhad Medical Sciences Branch, Islamic Azad University, Mashhad, Iran
Amirhossein Hashemi Attar Department of Radiology, Mashhad Medical Sciences Branch, Islamic Azad University, Mashhad, Iran

DOI: https://doi.org/10.18502/ijaai.v22i1.12000

Keywords: Airway remodeling; Asthma; Itraconazole; X-ray computed tomography

Abstract

The purpose of this study was to evaluate the effect of 8 months of treatment with itraconazole on airway wall thickness in patients with severe persistent asthma.

It was a double-blind, randomized, placebo-controlled clinical trial (IRCT20091111002695N9). Seventy-five subjects with severe persistent asthma received itraconazole (100 mg), prednisolone (5 mg), or placebo twice a day for eight months in three treatment groups (n=25 in each group). The primary objective was to improve the right upper lobe apical segmental bronchus (RB1) wall thickness percentage measured by high-resolution computed tomography scan of the lungs. Other morphometric measurements of RB1, asthma control test (ACT) score, presence of wheezing, dyspnea severity, rate of asthma exacerbation, fractional exhaled nitric oxide (FeNO), and expiratory volume in 1 second (FEV1) were set as the secondary outcomes.

Wall thickness percentage reduced significantly from 46% to 43.7% from pre- to post-treatment in the itraconazole-treated subjects. Similarly, lumen area and radius increased significantly in both the prednisolone and itraconazole groups. Itraconazole led to a significant improvement in wheezing, dyspnea severity, FEV1, ACT score, and FeNO. Although prednisolone was also effective in improving pulmonary function tests and ACT scores, it was associated with significantly more side effects than itraconazole.

Long-term treatment with itraconazole resulted in a significant reduction in bronchial wall thickness and improvements in clinical findings and pulmonary function tests. Thus, itraconazole could be a helpful add-on treatment option for severe persistent asthma patients to achieve better disease control.