Clinical Trial: Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Brief Summary:

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.

The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.


Detailed Summary:
Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome:

  • Glucocorticoid-dependent ABPA [ Time Frame: two year ]
  • relapse rates in the two groups [ Time Frame: one year ]


Original Primary Outcome:

  • remission rates in the two groups at six weeks and three months [ Time Frame: one year ]
  • percentage decline in IgE levels at six weeks and three months [ Time Frame: one year ]
  • complete remission rates in the two groups [ Time Frame: one year ]


Current Secondary Outcome:

  • time to first relapse [ Time Frame: one year ]
  • glucocorticoid related adverse effects in the two groups [ Time Frame: two years ]
  • response rates in the two groups [ Time Frame: six weeks ]


Original Secondary Outcome:

  • relapse rates in the two groups at six and 12 months after completion of glucocorticoid therapy [ Time Frame: two years ]
  • glucocorticoid related adverse effects in the two groups [ Time Frame: two years ]


Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: September 9, 2009
Date Started: April 2009
Date Completion:
Last Updated: February 22, 2015
Last Verified: February 2015