Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis (ITRACONASP)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 4

Conditions: Chronic Cavitary Pulmonary Aspergillosis

Treatments: Drug: Itraconazole; Drug: treatment in cavitary pulmonary aspergillosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01259336

Itracon asp

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Itraconazole

Active Comparator group

Description:

Role of itraconazole in CCPA

Treatment:

Drug: treatment in cavitary pulmonary aspergillosis

Drug: Itraconazole

treatment in cavitary pulmonary aspergillosis

Experimental group

Description:

Patients in this arm are given conservative management with antitussives, brochial artery embolisation.

Treatment:

Drug: treatment in cavitary pulmonary aspergillosis