Chronic Pulmonary Aspergillosis and Ambisome Aerosol With Itraconazole
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|ClinicalTrials.gov Identifier: NCT03656081|
Recruitment Status : Recruiting
First Posted : September 3, 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656081
|Contact: Marie Bonnin||+33 5 49 44 33 email@example.com|
|Poitiers, France, 86000|
|Contact: Laurent Vinet +33549443668 firstname.lastname@example.org|
|Principal Investigator:||Cendrine GODET, MD||Bichat Hospital, AP-HP|