Health Condition 1: J40-J47- Chronic lower respiratory diseases
Conditions
Interventions
Intervention1: Nebulised amphotericin B: Amphotericin B deoxycholate 50 mg by nebulisation given for 7 days
Control Intervention1: oral itraconazole: oral itraconazole 400mg/day given for 4 months
Sponsors
Intramural project of AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients having pulmonary aspergilloma on Computed tomography thorax with symptoms like cough, hemoptysis etc. 2) Age more than 18 years 3) Patients not having other concomitant respiratory infections
Exclusion criteria
Exclusion criteria: 1) Patients having severe constitutional features like high grade fever, massive hemoptysis etc. 2) Patients who have hypersensitivity to either azoles or Amphotericin B. 3) Patients not giving consent for bronchoscopic intervention or receiving nebulised Amphotericin B 4) overt immunosuppressive state (patients on immunosuppressive drugs, intake of prednisolone (or equivalent) >10 mg for at least 3 weeks, uncontrolled diabetes mellitus and others), 5) Invasive aspergillosis, ABPA, CNPA, active pulmonary tuberculosis or malignancy 6) Pregnancy 7) Patient who are not anti-fungal naïve (who has received antifungals through oral or iv route for more than 7 days in the last 6 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Clinical response based on assessment of patientâ??s sense of well-being, gain in weight, improvement in cough and exercise capacity, decrease in the number, and frequency and quantity of hemoptysis 2) Radiological response based on the size/number of the fungal balls, attenuation of the paracavitary infiltrates or pleural fibrosis. The response would be assessed objectively by measuring the longest diameter of various lesions and a 50% reduction would be taken as criteria for improvement. Timepoint: The symptoms and radiology (LDCT) would be repeated at 1,3 and 6 months of therapy (for amphotericin B) and 4 months and 6 months of therapy with itraconazole. The results would be computed and the two treatment arms would be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of nebulised amphotericin B and oral itraconazoleTimepoint: first 7 days, 1 month, 4 month and 6 month | — |
Countries
India
Contacts
Public ContactAnimesh Ray
AIIMS, New Delhi
Outcome results
None listed