Chronic Pulmonary Aspergillosis and Ambisome Aerosol With Itraconazole
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|ClinicalTrials.gov Identifier: NCT03656081|
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : June 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pulmonary Aspergillosis||Drug: inhaled Ambisome® Drug: inhaled placebo Drug: Itraconazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2023|
Placebo Comparator: Itraconazole & inhaled placebo
Itraconazole 200 mg x 2/day associated with inactive nebulised treatment (isotonic saline) twice a week during 24 weeks.
Drug: inhaled placebo
inhaled isotonic saline
Other Name: placebo (for Ambisome®)
Other Name: Sporanox®
Experimental: Itraconazole & inhaled Ambisome®
Itraconazole 200 mg x 2/day associated with inhaled liposomal amphotericin B (Ambisome®) at 25 mg twice a week during 24 weeks
Drug: inhaled Ambisome®
inhaled liposomal amphotericin B = inhaled LAmB
Other Name: Sporanox®
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656081
|Contact: Marie Bonnin||+33 5 49 44 33 firstname.lastname@example.org|
|Poitiers, France, 86000|
|Contact: Laurent Vinet +33549443668 email@example.com|
|Principal Investigator:||Cendrine GODET, MD||Bichat Hospital, AP-HP|