Status:
COMPLETED
A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Allergic Bronchopulmonary Aspergillosis
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).
Eligibility Criteria
Inclusion
- 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
- Failure to provide informed consent
- Pregnancy
- Involved in any other research protocol
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01857479
Start Date
May 1 2013
End Date
June 1 2015
Last Update
August 5 2015
Active Locations (1)
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1
Chest Clinic, PGIMER
Chandigarh, India, 160012