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Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis (ITRACONASP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vishwanath gella, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01259336
First received: December 6, 2010
Last updated: February 18, 2012
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Chronic Cavitary Pulmonary Aspergillosis
Drug: Itraconazole
Drug: treatment in cavitary pulmonary aspergillosis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • clinical improvement in cough and hemoptysis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Radiological response of CCPA to itraconazole [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 31
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Itraconazole
Role of itraconazole in CCPA
Drug: Itraconazole
Tablet 200 mg twice daily for 6 months
Other Name: 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)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259336

Locations
India
PGIMER
Chandigarh, Punjab, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Vishwananath gella, DM POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vishwanath gella, vgella, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01259336     History of Changes
Other Study ID Numbers: Itracon asp
Study First Received: December 6, 2010
Last Updated: February 18, 2012
Health Authority: INDIA: Institute review board, PGIMER, Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:
Itraconazole
chronic cavitary pulmonary aspergillosis
Aspergillosis
fungal ball
mycetoma
efficacy
safety

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Dermatomycoses
Hyalohyphomycosis
Infection
Lung Diseases
Lung Diseases, Fungal
Mycoses
Respiratory Tract Diseases
Skin Diseases
Skin Diseases, Infectious
Hydroxyitraconazole
Itraconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014