Clinical Trial: Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

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




Official Title: A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis

Brief Summary: This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Detailed Summary: Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. 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.Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.
Sponsor: Postgraduate Institute of Medical Education and Research




Current Primary Outcome:

  • Response rates in the two groups [ Time Frame: Six weeks and three months ]
    IgE levels decline by >=25 percent and there is clinical improvement with partial/total clearance of chest radiographic lesions [if pulmonary opacities have been previously present] after six and three months of treatment
  • Relapse rates in the two groups [ Time Frame: 12, 18, 24 months ]
    No ABPA exacerbations over the next 3 months after stopping therapy


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Participants with Adverse Events [ Time Frame: 4 months ]

Adverse events in the two groups


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research




Dates:
Date Received: June 12, 2012
Date Started: June 2013
Date Completion:
Last Updated: January 2, 2017
Last Verified: January 2017