A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis (RIA)

NCT02440009 Phase 2/Phase 3 COMPLETED

The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

Details

Lead sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	191
Start date	2014-05
Completion	2017-07-31

Conditions

• Allergic Bronchopulmonary Aspergillosis

Interventions

• Itraconazole
• Glucocorticoids

Primary outcomes

• Relapse rates — 12 months
  Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value
• Glucocorticoid-dependent ABPA — 24 months
  If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma

Countries

India