Status:
RECRUITING
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Bronchiectasis
Bronchiectasis Adult
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
There is an intricate link between bronchiectasis and fungi. Patients with cystic fibrosis frequently manifest fungal sensitization and fungal colonization with Aspergillus fumigatus.6 Aspergillus spe...
Detailed Description
Bronchiectasis is a chronic lung disease due to irreversible and abnormal dilatation of the bronchi. Bronchiectasis manifest with chronic cough, expectoration, hemoptysis, dyspnea, and others. Bronchi...
Eligibility Criteria
Inclusion
- adults subjects (≥13 years) with non-cystic fibrosis bronchiectasis fulfilling all the following criteria: • bronchiectasis on thin-section computed tomography (CT)
- chronic aspergillus infection defined by the presence of A.fumigatus-specific IgG ≥40 mgA/L
- clinically stable for at least three months prior to study inclusion
Exclusion
- We will exclude subjects with any of the following:
- allergic bronchopulmonary aspergillosis as the cause of underlying bronchiectasis
- cystic fibrosis
- post-tuberculosis bronchiectasis
- severe asthma
- current smokers
- active bacterial, mycobacterial (atypical or typical), or fungal (aspergillosis or mucormycosis) infections
- use of systemic antifungal drugs in past 3 months
- previous documented intolerance to itraconazole
- pregnancy
- failure to provide informed consent
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06160713
Start Date
December 1 2023
End Date
January 31 2026
Last Update
December 20 2023
Active Locations (1)
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1
Chest clinic
Chandigarh, India, 160012