TY - JOUR T1 - A randomised trial of prednisolone <em>versus</em> prednisolone and itraconazole in acute-stage allergic bronchopulmonary aspergillosis complicating asthma JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.01787-2021 VL - 59 IS - 4 SP - 2101787 AU - Ritesh Agarwal AU - Valliappan Muthu AU - Inderpaul Singh Sehgal AU - Sahajal Dhooria AU - Kuruswamy Thurai Prasad AU - Mandeep Garg AU - Ashutosh Nath Aggarwal AU - Arunaloke Chakrabarti Y1 - 2022/04/01 UR - http://erj.ersjournals.com/content/59/4/2101787.abstract N2 - Background Whether a combination of glucocorticoid and antifungal triazole is superior to glucocorticoid alone in reducing exacerbations in patients with allergic bronchopulmonary aspergillosis (ABPA) remains unknown. We aimed to compare the efficacy and safety of prednisolone–itraconazole combination versus prednisolone monotherapy in ABPA.Methods We randomised subjects with treatment-naïve acute-stage ABPA complicating asthma to receive either prednisolone alone (4 months) or a combination of prednisolone and itraconazole (4 and 6 months, respectively). The primary outcomes were exacerbation rates at 12 months and glucocorticoid-dependent ABPA within 24 months of initiating treatment. The key secondary outcomes were response rates, percentage decline in serum total IgE at 6 weeks, time to first ABPA exacerbation and treatment-emergent adverse events (TEAEs).Results We randomised 191 subjects to receive either prednisolone (n=94) or prednisolone–itraconazole combination (n=97). The 1-year exacerbation rate was 33% and 20.6% in the prednisolone monotherapy and prednisolone–itraconazole combination arms, respectively (p=0.054). None of the participants progressed to glucocorticoid-dependent ABPA. All of the subjects experienced a composite response at 6 weeks, along with a decline in serum total IgE (mean decline 47.6% versus 45.5%). The mean time to first ABPA exacerbation (417 days) was not different between the groups. None of the participants required modification of therapy due to TEAEs.Conclusions There was a trend towards a decline in ABPA exacerbations at 1 year with the prednisolone–itraconazole combination versus prednisolone monotherapy. A three-arm trial comparing itraconazole and prednisolone monotherapies with their combination, preferably in a multicentric design, is required to define the best treatment strategy for acute-stage ABPA.Combination therapy with prednisolone–itraconazole resulted in a nonsignificant decline in the occurrence of ABPA exacerbations at 1 year compared with prednisolone monotherapy in acute-stage ABPA complicating asthma https://bit.ly/2Yna4Lp ER -