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

Allergic Bronchopulmonary Aspergillosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857479
• Other study ID #: NK/708/Res/181
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 13, 2013
• Last updated: August 4, 2015
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: DSMC, PGI Chandigarh
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Inhaled budesonide
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 amphotericin
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.

Locations

Country	Name	City	State
India	Chest Clinic, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first relapse	Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels	12 months	No
Secondary	ACQ-7 scores between the two groups		2, 4, 6, and 12 months	No
Secondary	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	12 months	No
Secondary	Improvement in forced expiratory volume in the first second (FEV1)		2, 4, 6, and 12 months	No
Secondary	Adverse effects of therapy in both the arms		12 months	Yes