A Prospective Study of Prevalence of Severe Asthma With Fungalsensitization, and an Open Labelled, Randomized Controlled Trial Ofitraconazole in Patients Having Severe Asthma With Fungal Sensitization

Abstract

To evaluate the prevalence of Severe Asthma with Fungal Sensitization. To study the role of Itraconazole in patients of severe asthma with fungal sensitization by randomized controlled trial.METHODS: 100 patients with severe asthma were taken in for study. Aspergillus fumigatus specific skin prick test was done. Patients who showed positive skin prick test were ruled out ABPA. Absolute eosinophil count less than 1000/mm^3, Serum IgE less than 1000 IU/mL, HRCT lungs without features suggestive of ABPA were regarded as patients with SAFS. Patients with SAFS were taken in for randomised control study and were separated into 2 groups. All patients received basic asthma medications for severe category in addition group A received tablet Itraconazole 200mg BD for 12 weeks and group B received placebo. Symptomatic assessment was taken in account for the patients whether they had well controlled/ partially controlled/ uncontrolled asthma symptoms and compared with the outcome. Serial PFT was done for all patients. Serum IgE, Absolute Eosinophil count were repeated at the end of 12 weeks. RESULTS: 30(30%) participants were aged between 18 to 24 years, 23 (23%) were aged between 25 to 39 years, 40 (40%) were aged between 40 to 59 years and 7 (7%) were aged >60 years. 32 (32%) participants were male and 68 (68%) participants were female. 27 (27%) participants showed Positive Skin prick test to Aspergillus fumigatus specific antigen. Among the 27 patients, HRCT lungs showed features of allergic bronchopulmonary aspergillosis-CB in 5 (18.52%) participants and 22 (81.48%) had Normal HRCT. Based on Sr. IgE and absolute eosinophil count, 17 (62.96%) participants were categorised as having allergic bronchopulmonary aspergillosis and 10 (37.04%) participants with severe asthma with fungal sensitization. Among 10 SAFS patients 5(50%) were in group A and 5(50%) were in group B. Symptomatically all 10 patients had uncontrolled asthma. 5 participants with uncontrolled symptoms in Group A had their symptoms well controlled after 12 weeks. Among 5 participants with uncontrolled symptoms in Group B, 4 (80%) had partially controlled asthma and 1(20%) had uncontrolled asthma after 12 weeks. Out of 5 patients in Group A, PFT showed mild obstruction in 3(60%) and normal spirometry in 2(40%) after 12 weeks. In group B, PFT showed 1(20%) had mild obstruction and 3(60%) had moderate obstruction and 1(20%) had very severe obstruction after 12 weeks. Sr. IgE of patients taken at the beginning and at the end of study showed significant reduction in patients in group A with mean difference of 433.20 than group B where the mean difference was 175.56. Similarly, Absolute eosinophil count taken at the beginning and at the end of study showed significant reduction in patients in group A with mean difference of 303.60 than group B where the mean difference was 110.40. CONCLUSIONS:Patients in group A who received Itraconazole compared with group B patients who received placebo had improvement in their control of symptoms. Their pulmonary function improve...