Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

Post Graduate Institute of Medical Education and Research, Chandigarh31 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Cavitary Pulmonary Aspergillosis

Interventions

ItraconazoleDRUG

Tablet 200 mg twice daily for 6 months

treatment in cavitary pulmonary aspergillosisDRUG

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

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

PGIMER

Chandigarh, Punjab, India

Outcomes

Primary Outcomes

clinical improvement in cough and hemoptysis

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

Time frame: 6 months

Secondary Outcomes

Radiological response of CCPA to itraconazole

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

Time frame: 6 months

Data from ClinicalTrials.gov

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