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

Comparing two treatments for Chronic Pulmonary Aspergillosis

Official title: Therapeutic Efficacy Comparison of a Six-month Treatment by Itraconazole and Nebulised Ambisome® Versus Treatment by Itraconazole Alone in Non- or Mildly- Immunocompromised Patients with Chronic Pulmonary Aspergillosis: a Prospective, Randomized, Single Blind Study, (single Aspergilloma Excluded)

Run by Poitiers University Hospital · NCT03656081 · Data updated 2026-11-12

This study is testing if a combination of two treatments can help people with Chronic Pulmonary Aspergillosis feel better compared to using just one of the treatments alone.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment224 (estimated)
SponsorPoitiers University Hospital
Academic / other
Locations1 site (Poitiers)
StatusRecruiting
StartedDecember 19, 2018
Main results expectedJune 2027
Study endsDecember 2029
Registry record updatedFebruary 20, 2025
Trial IDNCT03656081 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Chronic Pulmonary Aspergillosis.

Probably not a fit

Patients with a history of resistance to itraconazole or those with single aspergillomas may 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 study evaluates the effectiveness of a six-month treatment regimen combining itraconazole with nebulized Ambisome® (liposomal amphotericin B) against itraconazole alone in patients with Chronic Pulmonary Aspergillosis. Participants will be randomly assigned to receive either the combination treatment or itraconazole with a placebo nebulizer. The study aims to assess both clinical and radiological outcomes over a follow-up period of 24 months after treatment cessation. Eligible patients include those with documented Aspergillus infections and no history of itraconazole resistance.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from Chronic Pulmonary Aspergillosis.

How similar studies have gone: Other studies have explored treatments for Chronic Pulmonary Aspergillosis, but the combination of nebulized Ambisome with itraconazole is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

All adult patients affected with Chronic Pulmonary Aspergillosis (CPA) "de novo" or in relapse (without any history of resistance to itraconazole) combining the following criteria are eligible:

1. Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic, necrotizing (SIA/Semi Invasive Aspergillosis) or nodular and documented by compatible thoracic CT-scan images ;
2. Associated with one of the following criteria:

   * positive detection of anti-Aspergillus IgG and/or precipitating anti-aspergillus antibodies, according to the positivity threshold of the laboratory performing the technique,
   * positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration),
   * revealing aspergillar hyphae/filaments on histological samples
3. Men or women age ≥ 18 years;
4. For the women of childbearing age: women having a negative serum pregnancy test, having a contraception highly effective and accepting to pursue it during at least the first 12 months of the study;
5. Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures;
6. Participants must be affiliated to France's Health Care Regime (" Sécurité Sociale ");
7. Free and informed consent signed by each participating patient.

Exclusion Criteria:

1. \- Patient affected with single aspergilloma
2. \- Patient presenting a contraindication to itraconazole (including all contraindicated co-administrated medications as listed in the itraconazole SmPc, including notably medications with potential to prolong theQT interval)
3. \- Patient presenting a contraindication to voriconazole and posaconazole (including all contraindicated coadministrated medications as listed in the SmPc)
4. \- Intolerance to beta2-agonists
5. \- Notion of relapse with isolation of an Aspergillus resistant to itraconazole
6. \- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent
7. \- Patient having presented complications related to a previous treatment by nebulised LAmB
8. \- Patient received an oral (excepted oral Amphotericin B), parenteral or intra-cavity antifungal treatment within the last 2 months
9. \- Severe renal failure (clearance \<30 ml / min).
10. \- Hepatic failure with transaminase and alkaline phosphatase values \> 5 times normal
11. \- Significant abnormality of the blood cell and platelet counts (at the discretion of the investigator)
12. \- Concomitant use of one or several of treatments contra-indicated with the experimental or non-experimental treatment
13. \- Ventricular dysfunction such as congestive cardiac failure or history of congestive cardiac failure or patients with risk(s) factors of cardiac arrhythmia or symptomatic arrhythmia with a prolongation of the corrected QT interval \> 450 msec in men and 470 msec in women or treated by medication known to prolong QT interval, or prolongation of the corrected QT interval \> 450 msec in men and 470 msec in women.
14. \- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
15. \- Chronic Pulmonary Aspergillosis with indication for surgical intervention within 6 months from the start
16. \- Patients with Cystic Fibrosis
17. \- Immunocompromised patients
18. \- Threatening hemoptysis, with impossibility to defer surgical procedures (but patients contraindicated to surgery may be included after resolution of the hemoptysis)
19. \- Tuberculosis or progressive non-tuberculous mycobacteria
20. \- Respiratory infection aggravating the underlying CPA (patient may be included after eradication of infection)
21. \- Patient refusing to participate
22. \- Protected majors in the meaning of the law, non affiliated persons or with no social security scheme, persons deprived of liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies.
23. \- Patient in exclusion period following participation in another interventional study evaluating antifungals or medicines
24. \- Women at age to procreate and not using highly effective contraception, pregnant or breastfeeding women

Where it's running

  • CHU Poitiers
    Poitiers, France
    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.