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 ]

Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels


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