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Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

ConditionChronic Pulmonary Aspergillosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ;

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

Disqualifiers

- 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • inhaled Ambisome®

    Drug

    inhaled liposomal amphotericin B = inhaled LAmB

  • inhaled placebo

    Drug

    inhaled isotonic saline

  • Itraconazole

    Drug

    Itraconazole tablet

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Itraconazole & inhaled placeboPlacebo comparator 2 interventions
Group B: Itraconazole & inhaled Ambisome®Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

major events during follow-up period

Time frame
month 6 to month 30
2

relapse

Time frame
month 6 to month 30
3

mycological response

Time frame
after 3 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poitiers University Hospital

Lead sponsor

Source ClinicalTrials.gov
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