Chronic Pulmonary AspergillosisPhase 3NCT03656081
Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
A Phase 3 study testing inhaled Ambisome® and Itraconazole in people with Chronic Pulmonary Aspergillosis, run by Poitiers University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- What is being tested?
- inhaled Ambisome® and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2018to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- - 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 interval)
- - 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
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- - 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 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.
- - 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 institution, adults under legal protection, and finally patients in emergencies.
- - Patient in exclusion period following participation in another interventional study evaluating antifungals or medicines
- - Women at age to procreate and not using highly effective contraception, pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Poitiers
Poitiers, 86000
Céline DELETAGE, +33549443854, celine.deletage@chu-poitiers.fr
About this study
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)
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.
- Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg twice a week during 24 weeks.
Follow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.
- Conditions
- Chronic Pulmonary Aspergillosis
- Being tested
- inhaled Ambisome®, inhaled placebo, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled Ambisome®Drug
inhaled liposomal amphotericin B = inhaled LAmB
inhaled placeboDrug
Also called placebo (for Ambisome®)
inhaled isotonic saline
ItraconazoleDrug
Also called Sporanox®
Itraconazole tablet
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole & inhaled placebo | Placebo comparator | Itraconazole 200 mg x 2/day associated with inactive nebulised treatment (isotonic saline) twice a week during 24 weeks. Receives: Drug: inhaled placebo; Drug: Itraconazole |
| Itraconazole & inhaled Ambisome® | Experimental | Itraconazole 200 mg x 2/day associated with inhaled liposomal amphotericin B (Ambisome®) at 25 mg twice a week during 24 weeks Receives: Drug: inhaled Ambisome®; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite efficacy criterion defined by the association of clinical improvement/stability and radiological improvement evaluated at 6 months
- Clinical improvement or stability is evaluated using the Respiratory Symptom Score based on 6 items (cough, expectoration, dyspnea, hemoptysis, chest pain, and nocturnal awakening ) quoted with a 10 cm visual analogical scale).
Stability is defined by a score variation between -25 and +25%, while improvement is defined by a decrease in score greater than 25%.
- Radiological improvement is based on the analysis of CT-scan parameters (a committee consisting on two chest radiologists wil perform centrally and parallel analyses of each CT-scan blinded to the study treatment allocation to reach a final decision by consensus)
The radiological improvement (binary variable) is defined by a consensual score based on the evolution of the various radiological parameters (cavity, fungus ball, alveolar condensation, nodules) according to validated thresholds.
Measured: 6 months
Secondary outcomes (3)
major events during follow-up period
Measured: month 6 to month 30
relapse
Measured: month 6 to month 30
mycological response
Measured: after 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start19 Dec 2018
- Primary completionJun 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cendrine GODET, MD, Principal investigator, Bichat Hospital, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656081
- Sponsor's protocol ID
- CPAAARI
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2018
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03656081
- Acronym / sponsor ID
- CPAAARI
- Conditions
- Chronic Pulmonary Aspergillosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg twice a week during 24 weeks.
Follow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole & inhaled placebo | Placebo comparator | Drug: inhaled placebo, Drug: ItraconazoleItraconazole 200 mg x 2/day associated with inactive nebulised treatment (isotonic saline) twice a week during 24 weeks. |
| Itraconazole & inhaled Ambisome® | Experimental | Drug: inhaled Ambisome®, Drug: ItraconazoleItraconazole 200 mg x 2/day associated with inhaled liposomal amphotericin B (Ambisome®) at 25 mg twice a week during 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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;
Key exclusion criteria (24 listed)
- - 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 interval)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled Ambisome®inhaled liposomal amphotericin B = inhaled LAmB | Drug | Itraconazole & inhaled Ambisome® |
| inhaled placeboAlso: placebo (for Ambisome®)inhaled isotonic saline | Drug | Itraconazole & inhaled placebo |
| ItraconazoleAlso: Sporanox®Itraconazole tablet | Drug | Itraconazole & inhaled Ambisome®, Itraconazole & inhaled placebo |
Primary outcome
Composite efficacy criterion defined by the association of clinical improvement/stability and radiological improvement evaluated at 6 months
Time frame: 6 months
• Clinical improvement or stability is evaluated using the Respiratory Symptom Score based on 6 items (cough, expectoration, dyspnea, hemoptysis, chest pain, and nocturnal awakening ) quoted with a 10 cm visual analogical scale). Stability is defined by a score variation between -25 and +25%, while improvement is defined by a decrease in score greater than 25%. • Radiological improvement is based on the analysis of CT-scan parameters (a committee consisting on two chest radiologists wil perform centrally and parallel analyses of each CT-scan blinded to the study treatment allocation to reach a final decision by consensus) The radiological improvement (binary variable) is defined by a consensual score based on the evolution of the various radiological parameters (cavity, fungus ball, alveolar condensation, nodules) according to validated thresholds.
3 secondary outcomes
major events during follow-up period
Time frame: month 6 to month 30
relapse
Time frame: month 6 to month 30
mycological response
Time frame: after 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pulmonary Aspergillosis
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
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Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
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Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cendrine GODET, MD principal investigator
Bichat Hospital, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing inhaled Ambisome® and Itraconazole in people with Chronic Pulmonary Aspergillosis, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline DELETAGE (+33 5 49 44 38 54, celine.deletage@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite efficacy criterion defined by the association of clinical improvement/stability and radiological improvement evaluated at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.