Chronic Cavitary Pulmonary Aspergillosis
Conditions
Keywords
Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety
Brief summary
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
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.
Interventions
DRUGItraconazole
Tablet 200 mg twice daily for 6 months
DRUGtreatment in cavitary pulmonary aspergillosis
Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement in cough and hemoptysis | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiological response of CCPA to itraconazole | 6 months | 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 |
Countries
India
Outcome results
None listed