Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Cavitary Pulmonary Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Itraconazole

Role of itraconazole in CCPA

Group Type ACTIVE_COMPARATOR

Itraconazole

Intervention Type DRUG

Tablet 200 mg twice daily for 6 months

treatment in cavitary pulmonary aspergillosis

Intervention Type DRUG

Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)

treatment in cavitary pulmonary aspergillosis

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

Group Type EXPERIMENTAL

treatment in cavitary pulmonary aspergillosis

Intervention Type DRUG

Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)

Interventions

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Itraconazole

Tablet 200 mg twice daily for 6 months

Intervention Type DRUG

treatment in cavitary pulmonary aspergillosis

Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)

Intervention Type DRUG

Other Intervention Names

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Study group

Eligibility Criteria

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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