Actively Recruiting
Therapeutic Efficacy Comparison of Six-month Treatment by Itraconazole and Nebulised Ambisome Versus Itraconazole Alone in Non- or Mildly-Immunocompromised Patients with Chronic Pulmonary Aspergillosis
Led by Poitiers University Hospital · Updated on 2025-02-20
224
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effects of two treatments for Chronic Pulmonary Aspergillosis (CPA) in adults who are not or only mildly immunocompromised. The study evaluates the clinical and radiological outcomes of a six-month therapy combining itraconazole with nebulised Ambisome4 (liposomal amphotericin B) against itraconazole alone. Patients with single aspergilloma are excluded from this study, which is a prospective, randomized, single-blind phase 3 trial sponsored by Poitiers University Hospital. Participants are assigned to one of two groups: the control group receives itraconazole 200 mg twice daily plus an inactive nebulised treatment (isotonic saline) twice weekly for 24 weeks, while the experimental group receives the same itraconazole dose combined with inhaled liposomal amphotericin B at 25 mg twice weekly for 24 weeks. The study includes a 24-month follow-up period after treatment ends, with a minimum follow-up of 12 months. During the study, participants will undergo clinical and radiological assessments to measure improvement or stability after six months of treatment. Additional evaluations include monitoring major events, relapse rates, and mycological response over 30 months. The primary outcome focuses on a composite measure of clinical and radiological improvement at six months. Safety and treatment adherence will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with Chronic Pulmonary Aspergillosis (new or relapsed) without history of itraconazole resistance
- Aspergillus lung infection confirmed by compatible thoracic CT scan
- Positive anti-Aspergillus antibodies, positive culture or histological evidence of aspergillar hyphae
- Men or women aged 18 years or older
- Women of childbearing age with negative pregnancy test using highly effective contraception for at least 12 months
- Legally free patients without custody or guardianship restrictions
- Affiliated to France's Health Care Regime (S�curit� Sociale)
- Signed informed consent
You will not qualify if you...
- Single aspergilloma diagnosis
- Contraindications to itraconazole or related medications
- Contraindications to voriconazole or posaconazole
- Beta2-agonist intolerance
- Known itraconazole-resistant Aspergillus relapse
- Hypersensitivity to liposomal amphotericin B, itraconazole, or study components
- Previous complications from nebulised liposomal amphotericin B
- Oral, parenteral, or intra-cavity antifungal treatment within last 2 months (excluding oral Amphotericin B)
- Severe renal failure (clearance <30 ml/min)
- Severe liver failure with high enzyme levels
- Significant blood cell or platelet abnormalities
- Use of contraindicated treatments
- Cardiac dysfunction or arrhythmia with prolonged QT interval
- Invasive pulmonary Aspergillosis or Allergic Bronchopulmonary Aspergillosis
- Need for surgery within 6 months
- Cystic Fibrosis
- Immunocompromised status
- Severe hemoptysis requiring urgent surgery
- Tuberculosis or progressive non-tuberculous mycobacteria
- Active respiratory infection worsening CPA
- Refusal to participate
- Legal or social restrictions preventing participation
- Recent participation in other antifungal interventional studies
- Women pregnant, breastfeeding, or not using effective contraception
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive treatment with Itraconazole tablets twice daily combined with either inhaled Ambisome® or inhaled placebo twice a week.
Twice weekly inhalation visits during treatment
Duration - Up to 24 months after treatment
Participants are monitored for major events, relapse, and mycological response after completing treatment.
Periodic visits between month 6 and month 30
Trial Site Locations
Total: 1 location
1
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
C
Céline DELETAGE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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