Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

Post Graduate Institute of Medical Education and Research, Chandigarh50 enrolled

Overview

This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - 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. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.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. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergic Bronchopulmonary Aspergillosis

Interventions

PrednisoloneDRUG

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. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma

VoriconazoleDRUG

Voriconazole 200 mg BD for 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Presence of all the following three criteria: * Immediate cutaneous hyperreactivity on aspergillus skin test * Elevated total IgE levels \> 1000 IU/mL * A fumigatus specific IgE levels \> 0.35 kUA/L And, two of the following criteria: * Presence of serum precipitating antibodies against A fumigatus * Fixed or transient radiographic pulmonary opacities * Total eosinophil count \> 1000/µL * Central bronchiectasis on HRCT Exclusion Criteria: * Failure to give informed consent * Intake of glucocorticoids for more than three weeks in the preceding six months * Enrollment in another trial of ABPA * Any exposure to azoles in the last six months

Locations (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Outcomes

Primary Outcomes

Response rates in the two groups

IgE levels decline by \>=25 percent and there is clinical improvement with partial/total clearance of chest radiographic lesions \[if pulmonary opacities have been previously present\] after six and three months of treatment

Time frame: Six weeks and three months

Relapse rates in the two groups

No ABPA exacerbations over the next 3 months after stopping therapy

Time frame: 12, 18, 24 months

Secondary Outcomes

Number of Participants with Adverse Events

Adverse events in the two groups

Time frame: 4 months

Data from ClinicalTrials.gov

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