Comparing Itraconazole with Standard Care for Chronic Aspergillus Infection in Bronchiectasis
A Randomized Controlled Trial to 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
This study is testing if adding the antifungal medication itraconazole to standard care can help adults with bronchiectasis and chronic Aspergillus infection have fewer flare-ups.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Pgimer |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT06160713 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of oral itraconazole combined with standard care compared to standard care alone in reducing exacerbations in patients with non-cystic fibrosis bronchiectasis who have chronic Aspergillus infection. The study will include adult participants who have been clinically stable for at least three months and have specific IgG levels indicating chronic infection. By investigating the role of itraconazole, the trial seeks to address the gap in understanding the impact of fungal infections on bronchiectasis exacerbations. The methodology involves monitoring exacerbation rates and lung function over the course of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 13 and older with non-cystic fibrosis bronchiectasis and chronic Aspergillus infection.
Not a fit: Patients with allergic bronchopulmonary aspergillosis, cystic fibrosis, or those currently experiencing active infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of exacerbations in patients suffering from bronchiectasis related to chronic Aspergillus infection.
How similar studies have performed: While the role of antifungal treatment in bronchiectasis is not extensively studied, there is emerging evidence suggesting potential benefits, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandigarh
- Chest clinic — Chandigarh, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.