Study PHASE I/IIa, PROSPECTIVE, Randomised AND DOUBLE CIEGO ON SECURITY AND EFICACE OF nebulised liposomal amphotericin as COADYUVANT TREATMENT OF INVASIVE PULMONARY ASPERGILOSIS (Q3171483): Difference between revisions
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(Removed claim: summary (P836): The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmon...) |
(Created claim: summary (P836): The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmonar...) |
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The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmonary aspergillosis who will be randomised (1:1) to receive NAL, 25 mg or nebulised placebo 3 times a week for 6 weeks. The primary objective is the safety of ALN in this scenario, including clinical tolerance and pharmacokinetic studies. Secondary objectives are presented (a) clinical efficacy, using criteria of complete response, partial, stability and progression or death, at week 6 and 12, (b) microbiological efficacy, using culture, galactomanan, BDGlucan and PCR Aspergillus in bronchoalveolar lavage on day 0 and week 6, and in serum; and c) to explore the usefulness of the standarised uptake value in PET-TAC performed on week + 6 in relation to a baseline PET-TAC as a surrogated response marker. Administration of ALN and placebo shall be carried out by electronic eFlowR vibrating membrane nebulisers or by nebulisers adapted in case of assisted ventilation. The following visits will be made to carry out the study: baseline, week 1,2,3,4,5.6 (efficacy and safety assessment), 9 and 12 (global assessment). (English) | |||||||||||||||
| Property / summary: The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmonary aspergillosis who will be randomised (1:1) to receive NAL, 25 mg or nebulised placebo 3 times a week for 6 weeks. The primary objective is the safety of ALN in this scenario, including clinical tolerance and pharmacokinetic studies. Secondary objectives are presented (a) clinical efficacy, using criteria of complete response, partial, stability and progression or death, at week 6 and 12, (b) microbiological efficacy, using culture, galactomanan, BDGlucan and PCR Aspergillus in bronchoalveolar lavage on day 0 and week 6, and in serum; and c) to explore the usefulness of the standarised uptake value in PET-TAC performed on week + 6 in relation to a baseline PET-TAC as a surrogated response marker. Administration of ALN and placebo shall be carried out by electronic eFlowR vibrating membrane nebulisers or by nebulisers adapted in case of assisted ventilation. The following visits will be made to carry out the study: baseline, week 1,2,3,4,5.6 (efficacy and safety assessment), 9 and 12 (global assessment). (English) / rank | |||||||||||||||
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| Property / summary: The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmonary aspergillosis who will be randomised (1:1) to receive NAL, 25 mg or nebulised placebo 3 times a week for 6 weeks. The primary objective is the safety of ALN in this scenario, including clinical tolerance and pharmacokinetic studies. Secondary objectives are presented (a) clinical efficacy, using criteria of complete response, partial, stability and progression or death, at week 6 and 12, (b) microbiological efficacy, using culture, galactomanan, BDGlucan and PCR Aspergillus in bronchoalveolar lavage on day 0 and week 6, and in serum; and c) to explore the usefulness of the standarised uptake value in PET-TAC performed on week + 6 in relation to a baseline PET-TAC as a surrogated response marker. Administration of ALN and placebo shall be carried out by electronic eFlowR vibrating membrane nebulisers or by nebulisers adapted in case of assisted ventilation. The following visits will be made to carry out the study: baseline, week 1,2,3,4,5.6 (efficacy and safety assessment), 9 and 12 (global assessment). (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 18:18, 12 October 2021
Project Q3171483 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Study PHASE I/IIa, PROSPECTIVE, Randomised AND DOUBLE CIEGO ON SECURITY AND EFICACE OF nebulised liposomal amphotericin as COADYUVANT TREATMENT OF INVASIVE PULMONARY ASPERGILOSIS |
Project Q3171483 in Spain |
Statements
48,500.0 Euro
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97,000.0 Euro
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50.0 percent
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1 January 2019
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31 March 2022
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FUNDACION INVESTIGACION BIOMEDICA HOSPITAL RAMON Y CAJAL
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40°25'0.12"N, 3°42'12.89"W
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28079
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Se pretende valorar la seguridad y eficacia de anfotericina B liposomal nebulizada (ALN) como terapia complementaria al tratamiento sistémico habitual en pacientes con aspergilosis pulmonar invasiva y la utilidad de una prueba no rutinaria como marcador subrogado de eficacia. Para ello se llevará a cabo un ensayo clínico fase I/IIa, de 3 años de duración, en un sólo centro, prospectivo, aleatorizado y doble ciego en pacientes con aspergilosis pulmonar probada o probable que reciban tratamiento sistémico habitual a los que se aleatorizará (1:1) a recibir ALN, 25 mg ó placebo nebulizado 3 veces por semana, durante 6 semanas. El objetivo primario es la seguridad de ALN en este escenario, incluyendo tolerancia clínica y estudios farmacocinéticos. Como objetivos secundarios se presentan a) eficacia clínica, utilizando criterios de respuesta completa, parcial, estabilidad y progresión o muerte, en semana 6 y 12, b) eficacia microbiológica, utilizando cultivo, galactomanano, BDGlucano y PCR Aspergillus en lavado broncoalveolar en día 0 y semana 6, y en suero; y c) explorar la utilidad del índice de captación metabólica SUV ( standarized uptake value ) en PET-TAC realizado en semana +6 en relación a un PET-TAC basal como marcador subrogado de respuesta. La administración de ALN y placebo se llevará a cabo mediante nebulizadores electrónicos de membrana vibrante eFlowR o mediante nebulizadores adaptados en caso de ventilación asistida. Para llevar a cabo el estudio se realizarán las siguientes visitas: basal, semana 1,2,3,4,5,6 (evaluación de eficacia y seguridad), 9 y 12 (evaluación global). (Spanish)
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The aim is to assess the safety and efficacy of nebulised liposomal amphotericin B (ALN) as complementary therapy to the usual systemic treatment in patients with invasive pulmonary aspergillosis and the usefulness of a non-routine test as a surrogacy marker of efficacy. To this end, a 3-year phase I/IIa clinical trial will be conducted in a single-centre, prospective, randomised, and double-blind trial in patients with proven or likely pulmonary aspergillosis who will be randomised (1:1) to receive NAL, 25 mg or nebulised placebo 3 times a week for 6 weeks. The primary objective is the safety of ALN in this scenario, including clinical tolerance and pharmacokinetic studies. Secondary objectives are presented (a) clinical efficacy, using criteria of complete response, partial, stability and progression or death, at week 6 and 12, (b) microbiological efficacy, using culture, galactomanan, BDGlucan and PCR Aspergillus in bronchoalveolar lavage on day 0 and week 6, and in serum; and c) to explore the usefulness of the standarised uptake value in PET-TAC performed on week + 6 in relation to a baseline PET-TAC as a surrogated response marker. Administration of ALN and placebo shall be carried out by electronic eFlowR vibrating membrane nebulisers or by nebulisers adapted in case of assisted ventilation. The following visits will be made to carry out the study: baseline, week 1,2,3,4,5.6 (efficacy and safety assessment), 9 and 12 (global assessment). (English)
12 October 2021
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Madrid
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Identifiers
PI18_00179
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