Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Comparing nebulized amphotericin B and saline for chronic pulmonary aspergillosis treatment

Official title: A Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral Itraconazole

Run by Post Graduate Institute of Medical Education and Research, Chandigarh · NCT06447402 · Data updated 2026-11-12

This study is testing if a nebulized form of amphotericin B can help people with chronic pulmonary aspergillosis feel better compared to using saline after they've already been treated with oral itraconazole.

More Chronic Pulmonary Aspergillosis trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment196 (estimated)
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh
Academic / other
Locations1 site (Chandigarh, Chandigarh)
StatusRecruiting
StartedJune 3, 2024
Main results expectedMay 1, 2027
Study endsAugust 31, 2027
Registry record updatedSeptember 22, 2026
Trial IDNCT06447402 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with chronic pulmonary aspergillosis who have completed 12 months of oral itraconazole therapy.

Probably not a fit

Patients currently on immunosuppressive drugs or with active pulmonary infections will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of nebulized amphotericin B compared to nebulized normal saline as a maintenance therapy for patients with chronic pulmonary aspergillosis (CPA) who have previously been treated with oral itraconazole. The study will involve patients who have completed 12 months of itraconazole therapy, assessing the safety and efficacy of the nebulized treatment approach. Given the significant burden of CPA and the limitations of current therapies, this trial seeks to provide a potentially more effective treatment option for this challenging condition.

Why it matters

Potential benefit: If successful, this study could offer a more effective maintenance therapy for patients with chronic pulmonary aspergillosis, potentially improving their quality of life and reducing mortality.

How similar studies have gone: Previous studies have indicated that nebulized amphotericin B may be non-inferior to oral itraconazole, but this approach is still being evaluated in larger populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* consecutive subjects with CPA who have received 12 months therapy with oral itraconazole

Exclusion Criteria:

(i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of \>10 mg prednisolone (or equivalent) for at least 3 weeks in last 3 months, or a diagnosis of human immunodeficiency virus syndrome, ; (iii) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (iv) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); (v) pregnancy.

Where it's running

  • Chest clinic
    Chandigarh, Chandigarh, India
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.