Tests itraconazole in adults with bronchiectasis and chronic Aspergillus infection
Tests an antifungal drug added to standard care in people with bronchiectasis and fungal infection.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Chandigarh, IndiaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with bronchiectasis that is not caused by cystic fibrosis and who have a long-lasting Aspergillus infection. It tests whether itraconazole for six months lowers flare-ups.
- Age
- The record lists a minimum age of 12 years. The inclusion criteria say 13 years or older.
- Sex
- All sexes can join.
- Disease stage
- Bronchiectasis seen on a thin-section CT scan. Clinically stable for at least three months before joining.
- Earlier treatment
- Cannot have used systemic antifungal drugs in the past 3 months.
- Biomarker or test result
- Chronic Aspergillus infection: A. fumigatus-specific IgG of 40 mgA/L or more.
Main reasons for not taking part
- Allergic bronchopulmonary aspergillosis as the cause of bronchiectasis
- Cystic fibrosis
- Bronchiectasis after tuberculosis
- Severe asthma
- Current smokers
Read by machine on 12 November 2026.
Where in India
- Chest clinicChandigarh, IndiaContact: Inderpaul S Sehgal, MD,DMTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Trial code
- NCT06160713
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: use of systemic antifungal drugs in past 3 months; previous documented intolerance to itraconazole; 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; We will exclude subjects with any of the following:; cystic fibrosis; severe asthma; current smokers; pregnancy.