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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

RecruitingPhase 3Ages 12 Years - anyAllPost Graduate Institute of Medical Education and …
NCT06160713 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 chr

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📋 Eligibility rules (as published)
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
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What it tests

  • Itraconazole 65 MG
  • Standard care
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Where

1 site
Chest clinic
Chandigarh, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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