Revision history of "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)

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9 October 2024

  • curprev 10:4510:45, 9 October 2024DG Regio talk contribs 78,327 bytes +4 Changed label, description and/or aliases in pt
  • curprev 10:4510:45, 9 October 2024DG Regio talk contribs 78,323 bytes +7 Set a claim value: summary (P836): O objetivo é avaliar a segurança e eficácia da anfotericina B lipossómica nebulizada (ALN) como terapêutica complementar ao tratamento sistémico habitual em doentes com aspergilose pulmonar invasiva e a utilidade de um teste não rotineiro como marcador de eficácia de gestação de substituição. Para o efeito, será realizado um ensaio clínico de fase I/IIa de 3 anos num ensaio monocêntrico, prospetivo, aleatorizado e em dupla ocultação em doentes com a...

22 March 2024

20 December 2023

12 June 2023

10 June 2023

18 August 2022

  • curprev 03:0603:06, 18 August 2022DG Regio talk contribs 77,044 bytes +53,278 Changed label, description and/or aliases in el, da, fi, mt, lv, sk, ga, cs, pt, et, hu, bg, lt, hr, sv, ro, sl, pl, nl, fr, de, it, es, and other parts: Adding translations: el, da, fi, mt, lv, sk, ga, cs, pt, et, hu, bg, lt, hr, sv, ro, sl, pl,

16 January 2022

17 December 2021

9 December 2021

4 December 2021

12 October 2021

  • curprev 18:1818:18, 12 October 2021DG Regio talk contribs 12,703 bytes +2,293 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...
  • curprev 18:1818:18, 12 October 2021DG Regio talk contribs 10,410 bytes −2,293 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...
  • curprev 17:5917:59, 12 October 2021DG Regio talk contribs 12,703 bytes +238 Changed label, description and/or aliases in en: translated_label
  • curprev 17:5917:59, 12 October 2021DG Regio talk contribs 12,465 bytes +2,293 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...

10 October 2021

9 October 2021

8 October 2021