Clinical Trial: A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).
Detailed Summary:
Sponsor: Postgraduate Institute of Medical Education and Research
Current Primary Outcome: Time to first relapse [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ACQ-7 scores between the two groups [ Time Frame: 2, 4, 6, and 12 months ]
- Number of asthma exacerbations requiring oral steroids [ Time Frame: 12 months ]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) [ Time Frame: 2, 4, 6, and 12 months ]
- Adverse effects of therapy in both the arms [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Postgraduate Institute of Medical Education and Research
Dates:
Date Received: May 13, 2013
Date Started: May 2013
Date Completion:
Last Updated: August 4, 2015
Last Verified: August 2015