Guideline topic: Pharmacological management of asthma
Evidence table 4.19: Allergic Bronchopulmonary Aspergillosis

Author

Year

Study type

Quality rating

Population

Comments

Stevens¹

2000

Randomised, double-blind, placebo controlled study.

Phase 1 = 16/52 blind Itraconazole 200 mg po bd vs placebo - steroid reduction

Phase 2 = 16/52 open label

Itraconazole 200 mg /day

for maintenance and safety

+

55 adult asthmatics with strictly defined ABPA (increased IgE, aspergillus specific IgE, skin prick +ve to aspergillus, precipitating IgG aspergillus

and pulmonary infiltrates),

FEV₁/FVC <0.7

Prednisolone > 10mg/day

Phase 1

1) No. of overall "responders"

2) No. able to reduced oral prednisolone by >50%

Phase 2

1)No. of responders changing from placebo to low dose open intraconazole

2) No. of patients relapsing on low dose itraconazole

13/28 vs 5/27
17/22 vs 14/25

8/20

nil

p = 0.04

This study examined effect of itraconazole in a group of highly selected asthmatics with strictly defined ABPA. A response to therapy was defined as a 50% reduction in oral prednisolone, a 25% decrease in serum IgE, 25% increase in exercise tolerance, an improvement in pulmonary function tests and an improvement or absence of radiological pulmonary infiltrates.

Itraconazole therapy facilitated a 50% reduction in prednisolone dose in a significantly higher no. of patients than placebo - at both high (during the blind) and low (during the open phase) dose. No replases were seen when the dose of Itraconazole was reduced by half. The incidence of side effects was similar in the placebo and the active groups.

Salez²

1999

Retrospective cohort

ICS + oral steroids - 14 patients

Exacerbations, oral steroids, dose on oral steroids. FEV, VC

200 0.93

22mg 6.5mg

12 7

1.43 1.79

2.81 3.15

P< 0.01

Consistent with itraconazole having an effect but scale difficult to judge.