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New treatment option for Chronic Pulmonary Aspergillosis
Official title Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
ClinicalTrials.gov ID: NCT03656081
What this study is testing
What is inhaled Ambisome®?
inhaled Ambisome® is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic pulmonary aspergillosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study compares the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® (liposomal amphotericin B = LAmB) versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded). Control arm: Itraconazole 200 mg x 2/day associated with inactive nebulised treatment twice a week during 24 weeks.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All adult patients affected with Chronic Pulmonary Aspergillosis (CPA) "de novo" or in relapse (without any history of resistance to itraconazole)...
- Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic, necrotizing (SIA/Semi Invasive Aspergillosis) or nodular and...
- 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...
- positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration),
You likely can't join if
- \- Patient affected with single aspergilloma
- \- Patient presenting a contraindication to itraconazole (including all contraindicated co-administrated medications as listed in the itraconazole...
- \- Patient presenting a contraindication to voriconazole and posaconazole (including all contraindicated coadministrated medications as listed in the...
- \- Intolerance to beta2-agonists
- \- Notion of relapse with isolation of an Aspergillus resistant to itraconazole
- \- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent
See the full eligibility 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:
- 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 ;
- 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
- Men or women age ≥ 18 years;
- 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;
- Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures;
- Participants must be affiliated to France's Health Care Regime (" Sécurité Sociale ");
- Free and informed consent signed by each participating patient.
- \- Patient affected with single aspergilloma
- \- 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...
- \- Patient presenting a contraindication to voriconazole and posaconazole (including all contraindicated coadministrated medications as listed in the SmPc)
- \- Intolerance to beta2-agonists
- \- Notion of relapse with isolation of an Aspergillus resistant to itraconazole
- \- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent
- \- Patient having presented complications related to a previous treatment by nebulised LAmB
- \- Patient received an oral (excepted oral Amphotericin B), parenteral or intra-cavity antifungal treatment within the last 2 months
- \- Severe renal failure (clearance \<30 ml / min).
- \- Hepatic failure with transaminase and alkaline phosphatase values \> 5 times normal
- \- Significant abnormality of the blood cell and platelet counts (at the discretion of the investigator)
- \- Concomitant use of one or several of treatments contra-indicated with the experimental or non-experimental treatment
- \- 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...
- \- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- \- Chronic Pulmonary Aspergillosis with indication for surgical intervention within 6 months from the start
- \- Patients with Cystic Fibrosis
- \- Immunocompromised patients
- \- Threatening hemoptysis, with impossibility to defer surgical procedures (but patients contraindicated to surgery may be included after resolution of the hemoptysis)
- \- Tuberculosis or progressive non-tuberculous mycobacteria
- \- Respiratory infection aggravating the underlying CPA (patient may be included after eradication of infection)
- \- Patient refusing to participate
- \- 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...
- \- Patient in exclusion period following participation in another treatment study evaluating antifungals or medicines
- \- Women at age to procreate and not using highly effective contraception, pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Poitiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poitiers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.