Ritesh Agarwal1, Sahajal Dhooria2, Inderpaul Singh Sehgal2, Ashutosh N Aggarwal2, Mandeep Garg3, Biman Saikia4, Digambar Behera2, Arunaloke Chakrabarti5. 1. Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: agarwal.ritesh@outlook.in. 2. Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 3. Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 4. Department of Immunopathology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 5. Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Abstract
OBJECTIVE: Whether itraconazole monotherapy is effective in the acute stage of allergic bronchopulmonary aspergillosis (ABPA) remains unknown. The goal of this study was to compare the efficacy and safety of itraconazole and prednisolone monotherapy in ABPA. METHODS:Treatment-naive subjects with ABPA complicating asthma (January 2012 to December 2013) were randomized to receive either oral itraconazole or prednisolone for 4 months. The study was not blinded. The primary outcomes were proportion of subjects exhibiting a composite response after 6 weeks, percent decline in IgE after treatment, and numbers of subjects experiencing exacerbation. The secondary outcomes included the time to first exacerbation, change in lung function, and treatment-related adverse effects. RESULTS: A total of 131 subjects (prednisolone group, n = 63; itraconazolegroup, n = 68) were included in the study. The number of subjects exhibiting a composite response was significantly higher in the prednisolone group compared with the itraconazole group (100% vs 88%; P = .007). The percent decline in IgE after 6 weeks and 3 months and the number of subjects with exacerbations after 1 and 2 years of treatment were similar in the two groups. The time to first exacerbation (mean: 437 vs 442 days) and the improvement in lung function after 6 weeks was also similar in the two groups. The occurrence of side effects was significantly higher in the glucocorticoid arm (P < .001). CONCLUSIONS:Prednisolone was more effective in inducing response than itraconazole in acute-stage ABPA. However, itraconazole was also effective in a considerable number and, with fewer side effects compared with prednisolone, remains an attractive alternative in the initial treatment of ABPA. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321827; URL: www.clinicaltrials.gov).
RCT Entities:
OBJECTIVE: Whether itraconazole monotherapy is effective in the acute stage of allergic bronchopulmonary aspergillosis (ABPA) remains unknown. The goal of this study was to compare the efficacy and safety of itraconazole and prednisolone monotherapy in ABPA. METHODS: Treatment-naive subjects with ABPA complicating asthma (January 2012 to December 2013) were randomized to receive either oral itraconazole or prednisolone for 4 months. The study was not blinded. The primary outcomes were proportion of subjects exhibiting a composite response after 6 weeks, percent decline in IgE after treatment, and numbers of subjects experiencing exacerbation. The secondary outcomes included the time to first exacerbation, change in lung function, and treatment-related adverse effects. RESULTS: A total of 131 subjects (prednisolone group, n = 63; itraconazole group, n = 68) were included in the study. The number of subjects exhibiting a composite response was significantly higher in the prednisolone group compared with the itraconazole group (100% vs 88%; P = .007). The percent decline in IgE after 6 weeks and 3 months and the number of subjects with exacerbations after 1 and 2 years of treatment were similar in the two groups. The time to first exacerbation (mean: 437 vs 442 days) and the improvement in lung function after 6 weeks was also similar in the two groups. The occurrence of side effects was significantly higher in the glucocorticoid arm (P < .001). CONCLUSIONS:Prednisolone was more effective in inducing response than itraconazole in acute-stage ABPA. However, itraconazole was also effective in a considerable number and, with fewer side effects compared with prednisolone, remains an attractive alternative in the initial treatment of ABPA. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321827; URL: www.clinicaltrials.gov).
Authors: David L Hava; Lisa Tan; Patrick Johnson; Aidan K Curran; Jason Perry; Steve Kramer; Katie Kane; Pauline Bedwell; Gary Layton; Clarie Swann; Dennis Henderson; Naimat Khan; Lucy Connor; Litza McKenzie; Dave Singh; James Roach Journal: Br J Clin Pharmacol Date: 2020-01-16 Impact factor: 4.335