A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Post Graduate Institute of Medical Education and Research, Chandigarh191 enrolled

Overview

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

The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

191

Conditions

Allergic Bronchopulmonary Aspergillosis

Interventions

ItraconazoleDRUG

Oral itraconazole 200 mg BD for 6 months

GlucocorticoidsDRUG

Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following: * asthma * immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels \>0.35 kUA/L * elevated total IgE levels \>1000 IU/mL and, two of the following features: * presence of precipitating antibodies against A.fumigatus in serum * fixed or transient radiographic pulmonary opacities * total eosinophil count \>1000/µL * bronchiectasis on HRCT chest Exclusion Criteria: * Intake of systemic glucocorticoids for more than three weeks in the preceding six months * Exposure to azoles in the last six months * Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others * Patient on immunosuppressive drugs * Pregnancy * Enrollment in another trial of ABPA * Failure to provide informed consent

Locations (1)

Chest Clinic, PGIMER

Chandigarh, India

Outcomes

Primary Outcomes

Relapse rates

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

Time frame: 12 months

Glucocorticoid-dependent ABPA

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

Time frame: 24 months

Secondary Outcomes

Proportion of patients with a response rates

Time frame: Six weeks

Percentage decline in IgE

Time frame: Six weeks

Time to first relapse

Time frame: Two years

Treatment-related adverse effects

Time frame: Six months

Data from ClinicalTrials.gov

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