NCT06160713RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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 species also has a cause-and-effect relationship with non-CF (cystic fibrosis) bronchiectasis.7, 8 In allergic bronchopulmonary aspergillosis (ABPA), Aspergillus is the cause of bronchiectasis. In contrast, in other causes of bronchiectasis, A fumigatus can theoretically promote allergic response, which may result in poor lung function, increase the risk of exacerbations, and even cause ABPA over time.9, 10 In a recent study, we found an overall prevalence of Aspergillus sensitization of 29.5% and the prevalence of chronic aspergillus infection was 76%.11 The prevalence of chronic aspergillus colonization in non-(tuberculosis) TB-non-CF fibrosis was 47.5% (49/103).11 By mechanism similar to chronic bacterial colonization, chronic aspergillus infection or aspergillus sensitization can increase the risk of bronchiectasis exacerbation. Therefore, eradication of A. fumigatus from the airways of patients with bronchiectasis would decrease the future risk of a bronchiectasis exacerbation. Notably, in ABPA, use of itraconazole and voriconazole reduce the exacerbations by reducing the fungal burden in the airways.12, 13 In this randomized trial, we will investigate whether treatment with oral itraconazole for six months would reduce the future risk of bronchiectasis exacerbation in patients with non-CF-non-ABPA bronchiectasis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Nov 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- Cystic fibrosis
- NCT number
- NCT06160713
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 80
- From 1 Dec 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of systemic antifungal drugs in past 3 months
- previous documented intolerance to itraconazole
Other illness
- allergic bronchopulmonary aspergillosis as the cause of underlying bronchiectasis
- post-tuberculosis bronchiectasis
- active bacterial, mycobacterial (atypical or typical), or fungal (aspergillosis or mucormycosis) infections
- failure to provide informed consent
Other
- We will exclude subjects with any of the following:
- cystic fibrosis
- severe asthma
- current smokers
- pregnancy
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chest clinic Coordinator of this site? Confirm its status | Chandigarh | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.