Clinical Trial: A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Brief Summary: The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

Detailed Summary:

The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely 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.

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. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.


Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome:

  • Relapse rates [ Time Frame: 12 months ]
    Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value
  • Glucocorticoid-dependent ABPA [ Time Frame: 24 months ]
    If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients with a response rates [ Time Frame: Six weeks ]
  • Percentage decline in IgE [ Time Frame: Six weeks ]
  • Time to first relapse [ Time Frame: Two years ]
  • Treatment-related adverse effects [ Time Frame: Six months ]


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: May 1, 2015
Date Started: May 2015
Date Completion: June 2017
Last Updated: April 25, 2017
Last Verified: April 2017