Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis

NCT01321827 ↗

Phase 2/3 Completed 100 enrolled Post Graduate Institute of Medical Education and Research, Chandigarh

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2011-04
Primary completion: 2013-03
Completion: 2015-12

Outcome

Missed primary endpoint

paper 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). PMID 29331473 ↗

Publications

Agarwal R, Dhooria S, Singh Sehgal I, Aggarwal AN, Garg M, Saikia B, Behera D, Chakrabarti A. A Randomized Trial of Itraconazole vs Prednisolone in Acute-Stage Allergic Bronchopulmonary Aspergillosis Complicating Asthma. Chest. 2018 Mar;153(3):656-664. doi: 10.1016/j.chest.2018.01.005. Epub 2018 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Prednisolone	Other / unclassified	0.125 mg/kg	Oral