Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

Study Overview
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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

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.

Official Title
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A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS

Conditions
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Chronic Cavitary Pulmonary Aspergillosis

Intervention / Treatment
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* Drug: Itraconazole
* Drug: treatment in cavitary pulmonary aspergillosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks. 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. 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. The diagnosis of CCPA will be made if Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria. FNAC from the cavity wall will be considered in atypical cases Exclusion Criteria: Invasive aspergillosis Allergic broncho-pulmonary aspergillosis (ABPA) Active tuberculosis or malignancy Pregnant females

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological response of CCPA to itraconazole | Complete response- It is defined as complete disappearance of the aspergilloma. Partial response- It is defined as 30% decrease in the sum of the longest diameters of all the lesions. 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. Stable disease- Shrinkage or growth of CCPA that does not meet any of these criteria | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety