Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis (ITRACONASP)

February 18, 2012 updated by: Vishwanath gella, Postgraduate Institute of Medical Education and Research

A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Inclusion Criteria:

    1. Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks.

    2. Radiological findings:

      • Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation.
      • presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions.
    3. Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.

  2. The diagnosis of CCPA will be made if

    1. Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria.
    2. FNAC from the cavity wall will be considered in atypical cases

  3. Exclusion Criteria:

    1. Invasive aspergillosis
    2. Allergic broncho-pulmonary aspergillosis (ABPA)
    3. Active tuberculosis or malignancy
    4. Pregnant females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Itraconazole
Role of itraconazole in CCPA
Drug: Itraconazole
Tablet 200 mg twice daily for 6 months
Other Names:
  • Study group
Drug: treatment in cavitary pulmonary aspergillosis
Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
Experimental: treatment in cavitary pulmonary aspergillosis
Patients in this arm are given conservative management with antitussives, brochial artery embolisation.
Drug: treatment in cavitary pulmonary aspergillosis
Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Vishwananath gella, DM, Post Graduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 18, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Itracon asp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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