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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Bronchopulmonary Aspergillosis

Treatments: Drug: Inhaled budesonide; Drug: Inhaled amphotericin

Study type: Interventional

Funder types: Other

Identifiers

NCT01857479

NK/708/Res/181

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Inhaled budesonide

Active Comparator group

Description:

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 \[max 10 puff/day\]

Treatment:

Drug: Inhaled budesonide

Inhaled budesonide plus amphotericin

Experimental group

Description:

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.

Treatment:

Drug: Inhaled budesonide

Drug: Inhaled amphotericin