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

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Dec 6, 2023

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ClinConnect Summary

This clinical trial is studying whether taking a medication called oral itraconazole for six months can help reduce flare-ups in patients with a lung condition called bronchiectasis who also have a chronic infection caused by a fungus called Aspergillus. In bronchiectasis, the airways are damaged, which can lead to frequent infections and breathing problems. The researchers want to see if treating the fungal infection can improve lung health and decrease the number of flare-ups that these patients experience.

To participate in this trial, individuals must be at least 13 years old and diagnosed with non-cystic fibrosis bronchiectasis, confirmed by a specific type of lung scan. They should also have a chronic Aspergillus infection, indicated by certain blood test results, and must have been stable (not having serious symptoms) for the past three months. Participants will receive either the itraconazole treatment or standard care and will be monitored closely throughout the study. It's important to note that people with certain conditions, like cystic fibrosis or severe asthma, or those who are currently pregnant, cannot participate in this trial.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: 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 Criteria:
• 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