Clinical Trial: Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

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

Official Title: A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS

Brief Summary: The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis

Detailed Summary: The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: clinical improvement in cough and hemoptysis [ Time Frame: 6 months ]

Clinical response- assessed by a decrease in frequency & intensity of hemoptysis & cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response


Original Primary Outcome: Same as current

Current Secondary Outcome: Radiological response of CCPA to itraconazole [ Time Frame: 6 months ]

  1. Complete response- It is defined as complete disappearance of the aspergilloma.
  2. Partial response- It is defined as 30% decrease in the sum of the longest diameters of all the lesions.
  3. Progressive disease- It is defined as appearance of any new lesions or >20% increase in the sum of the longest diameters of all measurable lesions.
  4. Stable disease- Shrinkage or growth of CCPA that does not meet any of these criteria


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: December 6, 2010
Date Started: July 2010
Date Completion:
Last Updated: February 18, 2012
Last Verified: November 2010