A study on comparison between itraconazole tablets taken orally versus amphotericin B taken by nebulisation in patients with lung aspergilloma

Not Applicable

Completed

• Conditions: Health Condition 1: J40-J47- Chronic lower respiratory diseases

• Registration Number: CTRI/2018/11/016266
• Lead Sponsor: Intramural project of AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>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. <br/ ><br> <br/ ><br>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 Outcome Measures

Name	Time	Method
Side effects of nebulised amphotericin B and oral itraconazoleTimepoint: first 7 days, 1 month, 4 month and 6 month