6/28/23, 12:21 AM CPA (itraconazole) Pathway Feedback Search Clinical Topics Home Studies CPA (itraconazole) CPA (itraconazole) Disease Invasive aspergillosis Trial question Is 12-month oral itraconazole superior to 6-month itraconazole in patients with chronic pulmonary aspergillosis? Study design Single center Open label RCT Population Characteristics of study participants 48.0% female N = 164 52.0% male 164 patients (78 female, 86 male) Inclusion criteria: adult patients with chronic pulmonary aspergillosis who were naive to antifungal treatment Key exclusion criteria: receipt of antifungal azoles for > 3 weeks in the preceding 6 months; active mycobacterium tuberculosis or NTM pulmonary disease; other forms of pulmonary aspergillosis Interventions N=83 12-month itraconazole (an oral dose of 400 mg/day for 12 months) N=81 6-month itraconazole (an oral dose of 400 mg/day for 6 months) Primary outcome Relapse at 2 years 38.0 % 38 https://web.pathway.md/studies/recLXBWWxGRV30tEd 1/2 6/28/23, 12:21 AM CPA (itraconazole) Pathway 28.5 % 19.0 % Significant decrease 10 9.5 % NNT = 4 0.0 % 12-month itraconazole 6-month itraconazole Significant decrease in relapse at 2 years (10% vs. 38%; ARD -29, 95% CI -16 to -40) Secondary outcomes Significant increase in time to first relapse (23 months vs. 18 months; AD 5 months, 95% CI 2.5 to 7.5) Safety outcomes No significant differences in nausea, anorexia, ankle edema, other adverse events. Conclusion In adult patients with chronic pulmonary aspergillosis who were naive to antifungal treatment, 12- month itraconazole was superior to 6-month itraconazole with respect to relapse at 2 years. Reference Inderpaul S Sehgal, Sahajal Dhooria, Valliappan Muthu et al. Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis. 2022 Jul;22(7):1052-1061. Open reference URL https://web.pathway.md/studies/recLXBWWxGRV30tEd 2/2