Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis (MIPA)

NCT01321827 Phase 2/Phase 3 COMPLETED

The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy in patients with ABPA.

Details

Lead sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	100
Start date	2011-04
Completion	2015-12

Conditions

• Allergic Bronchopulmonary Aspergillosis

Interventions

• Glucocorticoids
• Itraconazole

Primary outcomes

• Remission rates in the two groups at six weeks and three months — 6 weeks, 3 months
  Remission - if the IgE levels decline by \>=25% and there is clinical improvement with partial/total clearance of chest radiographic lesions after three months of glucocorticoids (if previously present pulmonary opacities)
• Percentage decline in IgE levels at six weeks and three months — 6 weeks, 3 months
  IgE levels will be noted at baseline six weeks and three months after glucocorticoid therapy and percentage decline will be calculated as: (baseline IgE levels minus IgE levels after six weeks of treatment) divided by baseline IgE levels
• Complete remission rates in the two groups — 3 months, 6 months
  No ABPA exacerbations over the next 3 months after stopping therapy

Countries

India