Back to resultsA Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
Primary Purpose
Allergic Bronchopulmonary Aspergillosis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Inhaled budesonide
Inhaled amphotericin
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis focused on measuring ABPA
Eligibility Criteria
Inclusion Criteria: ABPA in remission defined as follows:
- Age 12-65 years
- Diagnosis of ABPA in the Chest Clinic
- 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).
- 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:
- Failure to provide informed consent
- Pregnancy
- Involved in any other research protocol
Sites / Locations
- Chest Clinic, PGIMER
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Inhaled budesonide
Inhaled budesonide plus amphotericin
Arm 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]
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.
Outcomes
Primary Outcome Measures
Time to first relapse
Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels
Secondary Outcome Measures
ACQ-7 scores between the two groups
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
Improvement in forced expiratory volume in the first second (FEV1)
Adverse effects of therapy in both the arms
Full Information
NCT ID
NCT01857479
First Posted
May 13, 2013
Last Updated
August 4, 2015
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01857479
Brief Title
A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergillosis
Keywords
ABPA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled budesonide
Arm Type
Active Comparator
Arm 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]
Arm Title
Inhaled budesonide plus amphotericin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Inhaled budesonide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Inhaled amphotericin
Intervention 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.
Primary Outcome Measure Information:
Title
Time to first relapse
Description
Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ACQ-7 scores between the two groups
Time Frame
2, 4, 6, and 12 months
Title
Number of asthma exacerbations requiring oral steroids
Description
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
Title
Improvement in forced expiratory volume in the first second (FEV1)
Time Frame
2, 4, 6, and 12 months
Title
Adverse effects of therapy in both the arms
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ABPA in remission defined as follows:
Age 12-65 years
Diagnosis of ABPA in the Chest Clinic
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).
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:
Failure to provide informed consent
Pregnancy
Involved in any other research protocol
Facility Information:
Facility Name
Chest Clinic, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
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