Comparing nebulized amphotericin B and saline for chronic pulmonary aspergillosis treatment
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
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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT06447402 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with chronic pulmonary aspergillosis who have completed 12 months of oral itraconazole therapy.
Not a fit: Patients currently on immunosuppressive drugs or with active pulmonary infections will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chandigarh
- Chest clinic — Chandigarh, India (Recruiting)
Study contacts
- Study coordinator: Inderpaul S Sehgal, MD, DM
- Email: inderpgi@outlook.com
- Phone: 91-172-2756823
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.