A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis

Post Graduate Institute of Medical Education and Research, Chandigarh21 enrolled

Overview

Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergic Bronchopulmonary Aspergillosis

Interventions

Inhaled budesonideDRUG

The control group will receive only nebulized budesonide 1 mg b.i.d. thrice a week for four months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]. The first dose will be administered under direct supervision. If the first dose is tolerated, therapy would be continued for the total duration of the study (4 months). The patient will be advised to clean the nebulizer chamber with soap and water after each administration to avoid contamination.

Inhaled amphotericinDRUG

Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]. The first dose will be administered under direct supervision.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: ABPA in remission defined as follows: 1. Age 12-65 years 2. Diagnosis of ABPA in the Chest Clinic 3. Received glucocorticoids for management of ABPA according to the Chest clinic protocol (0.5 mg/kg/day for 4 weeks, 0.25 mg/kg/day for 4 weeks, 0.125 mg/kg/day for 4 weeks, subsequently taper and stop steroids over the next 4 weeks). 4. Clinicoradiologic improvement with decline in IgE levels. The chest radiograph and IgE levels after four months of steroid therapy would serve as the baseline Exclusion Criteria: 1. Failure to provide informed consent 2. Pregnancy 3. Involved in any other research protocol

Locations (1)

Chest Clinic, PGIMER

Chandigarh, India

Outcomes

Primary Outcomes

Time to first relapse

Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels

Time frame: 12 months

Secondary Outcomes

ACQ-7 scores between the two groups

Time frame: 2, 4, 6, and 12 months

Number of asthma exacerbations requiring oral steroids

During each exacerbation, chest radiograph and IgE levels will be performed; Asthma exacerbation will be defined as worsening asthma control without radiological changes consistent with ABPA exacerbation and absence of doubling of baseline IgE levels

Time frame: 12 months

Improvement in forced expiratory volume in the first second (FEV1)

Time frame: 2, 4, 6, and 12 months

Adverse effects of therapy in both the arms

Time frame: 12 months

Data from ClinicalTrials.gov

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