ES2547489T3 - Un procedimiento de administración de un tensioactivo pulmonar - Google Patents
Un procedimiento de administración de un tensioactivo pulmonar Download PDFInfo
- Publication number
- ES2547489T3 ES2547489T3 ES08758716.8T ES08758716T ES2547489T3 ES 2547489 T3 ES2547489 T3 ES 2547489T3 ES 08758716 T ES08758716 T ES 08758716T ES 2547489 T3 ES2547489 T3 ES 2547489T3
- Authority
- ES
- Spain
- Prior art keywords
- pulmonary surfactant
- procedure
- administering
- pressure
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/42—Respiratory system, e.g. lungs, bronchi or lung cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0082—Lung surfactant, artificial mucus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/395—Alveolar surfactant peptides; Pulmonary surfactant peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pulmonology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Cell Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Developmental Biology & Embryology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Organic Chemistry (AREA)
- Virology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Una composición farmacéutica que comprende al menos 40 mg/ml de un tensioactivo pulmonar suspendido en no más de 3,0 ml de un medio acuoso farmacéuticamente aceptable, que tiene una viscosidad inferior a 20 mPas para su uso en la prevención y/o el tratamiento de un paciente que padece un síndrome disneico al cual se le aplica, con un dispositivo nasal, una presión positiva continua nasal en las vías respiratorias, a una presión de 1 a 12 cm de agua, en el que dicha composición es administrada en la tráquea de dicho paciente mediante una sonda que tiene un diámetro de 5 Fr que es retirada al final de la administración.
Description
E08758716
17-09-2015
corporal) se instila en la tráquea durante 1-5 minutos.
- •
- Después de esto, la sonda gástrica se extrae.
- •
- La observación cercana del niño durante el procedimiento es obligatoria.
- •
- La administración del tensioactivo puede repetirse si la FiO2 supera el 0,4.
5 • La entubación y la administración del tensioactivo intratraqueal debe considerarse si la FiO2 supera el 0,6 o si el niño padece distrés respiratorio severo.
• Los restantes tratamientos se realizan de acuerdo con estándares locales.
Medición de resultado principal:
• La intubación y la ventilación mecánica entre 25 y 72 h de vida. 10 • o
- •
- FiO2 >0,6 (para mantener la saturación de oxígeno por encima del 85%) entre 25 y 72 h de vida. • o
- •
- pCO2 > 65 mm Hg durante más de dos horas entre las 25 y 72 h de vida.
Tamaño de la muestra:
15 Basándose en los datos del estudio multicéntrico actual, se esperaba una frecuencia de medición de resultado principal en el grupo de control del 60 % frente al 40% en el grupo de intervención. Dado que el 50% de los recién nacidos se distribuyen aleatoriamente en el grupo de control, se necesitará un total de 210 niños (105 en cada grupo) para ensayar la hipótesis principal (p=0,05; error beta de 0,2; bilateral). Dado que en los centros participantes se trataban 250 pacientes/año que se elegían para el estudio y que se calculó un 60% de tasa de inclusión, bastaría
20 con un período de 60 meses para ensayar la hipótesis principal.
Resultados secundarios:
Tasa de ventilación, HIV, LPV, DBP, muerte, operación debido a retinopatía (ROP), ducto arterioso patente (DAP), enterocolitis necrotizante (ECN), perforación intestinal, hidrocefalia y derivación peritoneal ventricular, cantidad de dosis de tensioactivo, tensioactivo total (mg/kg de peso corporal), días con ventilación asistida, días con oxígeno
25 complementario, duración de la hospitalización, aumento de peso por día, neumotórax, otras complicaciones de prematuridad (las mismas definiciones que para el estudio genético).
Procedimientos contra el sesgo:
Los recién nacidos se distribuyen al azar antes de la intubación. Para impedir el posible sesgo de que los niños en el grupo de intervención no se intuban aunque cumplan los criterios de intubación local, se definió un criterio de
30 valoración primario combinado usando una FiO2 >0,6 para ganar una saturación > 85% y/o pCO2 > 65 mm Hg durante más de dos horas durante las 25-72 h como un indicador de fracaso del tratamiento. Los enfermeros(as) observan y registran los niveles de FiO2 y de pCO2. En el grupo control no es posible realizar un procedimiento oculto y simulado.
7
Claims (1)
-
imagen1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/811,351 US8048043B2 (en) | 2007-06-08 | 2007-06-08 | Method of administration of a pulmonary surfactant |
| US811351 | 2007-06-08 | ||
| PCT/EP2008/004120 WO2008148469A1 (en) | 2007-06-08 | 2008-05-23 | A method of administration of a pulmonary surfactant |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2547489T3 true ES2547489T3 (es) | 2015-10-06 |
Family
ID=39832595
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES08758716.8T Active ES2547489T3 (es) | 2007-06-08 | 2008-05-23 | Un procedimiento de administración de un tensioactivo pulmonar |
| ES14150705.3T Active ES2616727T3 (es) | 2007-06-08 | 2008-05-23 | Un procedimiento de administración de un tensioactivo pulmonar |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES14150705.3T Active ES2616727T3 (es) | 2007-06-08 | 2008-05-23 | Un procedimiento de administración de un tensioactivo pulmonar |
Country Status (23)
| Country | Link |
|---|---|
| US (2) | US8048043B2 (es) |
| EP (2) | EP2164504B1 (es) |
| JP (1) | JP5490683B2 (es) |
| KR (2) | KR101344159B1 (es) |
| CN (1) | CN101765431B (es) |
| AU (1) | AU2008258872B2 (es) |
| BR (1) | BRPI0811387B8 (es) |
| CA (1) | CA2690097C (es) |
| CY (2) | CY1116680T1 (es) |
| DK (2) | DK2164504T3 (es) |
| EA (1) | EA016308B1 (es) |
| ES (2) | ES2547489T3 (es) |
| HK (1) | HK1141457A1 (es) |
| HR (2) | HRP20150966T1 (es) |
| HU (2) | HUE025957T2 (es) |
| LT (1) | LT2719391T (es) |
| ME (1) | ME02327B (es) |
| MX (2) | MX359316B (es) |
| PL (2) | PL2164504T3 (es) |
| PT (2) | PT2719391T (es) |
| RS (2) | RS54196B1 (es) |
| SI (2) | SI2164504T1 (es) |
| WO (1) | WO2008148469A1 (es) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2475373B1 (en) * | 2009-09-08 | 2013-11-13 | Chiesi Farmaceutici S.p.A. | A therapeutic combination comprising a pulmonary surfactant and antioxidant enzymes |
| RU2504395C1 (ru) * | 2012-07-13 | 2014-01-20 | ФЕДЕРАЛЬНОЕ ГОСУДАРСТВЕННОЕ БЮДЖЕТНОЕ УЧРЕЖДЕНИЕ "РОССИЙСКИЙ НАУЧНЫЙ ЦЕНТР РАДИОЛОГИИ И ХИРУРГИЧЕСКИХ ТЕХНОЛОГИЙ" МИНИСТЕРСТВА ЗДРАВООХРАНЕНИЯ И СОЦИАЛЬНОГО РАЗВИТИЯ РОССИЙСКОЙ ФЕДЕРАЦИИ/ФГБУ "РНЦРХТ" Минздравсоцразвития России | Способ профилактики бронхолегочной дисплазии у новорожденных с очень низкой и экстремально низкой массой тела при рождении |
| ITMI20150033U1 (it) * | 2015-02-13 | 2016-08-13 | Chiesi Farm Spa | Catetere per la somministrazione di un surfattante polmonare |
| EP3277351B1 (en) | 2015-04-02 | 2019-06-05 | Hill-Rom Services PTE. LTD. | Manifold for respiratory device |
| US11311691B2 (en) | 2015-04-28 | 2022-04-26 | Chiesi Farmaceutici S.P.A | Device for facilitating the administration of a medicament to the lung by a catheter |
| WO2016174269A1 (en) * | 2015-04-30 | 2016-11-03 | University Of Bremen | A novel skin medical and cosmetic care product |
| EP3490649A1 (en) | 2016-07-28 | 2019-06-05 | Chiesi Farmaceutici S.p.A. | Method and system for delivery of an aerosolized medicament |
| MA46605A (fr) | 2016-10-26 | 2021-06-02 | Chiesi Farm Spa | Dispositif permettant de faciliter l'administration d'un médicament aux poumons par l'intermédiaire d'un cathéter |
| JP2020502242A (ja) | 2016-12-22 | 2020-01-23 | キエージ・フアルマチエウテイチ・エツセ・ピ・ア | 進行性のｂｐｄの処置のための肺サーファクタント及びステロイドを含む処置的組み合わせ物 |
| AU2019260526A1 (en) | 2018-04-23 | 2020-11-19 | Chiesi Farmaceutici S.P.A. | A therapeutic combination comprising a pulmonary surfactant and a steroid for the prophylaxis of BPD |
| MA54367A (fr) | 2018-12-06 | 2021-11-10 | Chiesi Farm Spa | Dispositif de contrôle des voies aériennes à masque laryngé et procédé d'administration d'un médicament à travers un dispositif de contrôle des voies aériennes à masque laryngé |
| US11219843B2 (en) * | 2019-07-08 | 2022-01-11 | Nik Paya Karen Pharmed | Extraction of animal-derived pulmonary surfactants |
| WO2021151853A1 (en) | 2020-01-28 | 2021-08-05 | Chiesi Farmaceutici S.P.A. | Polypeptides having improved properties |
| AU2022306466A1 (en) * | 2021-07-05 | 2024-02-15 | Chiesi Farmaceutici S.P.A. | Process for the preparation of a pulmonary surfactant |
| CN115634199B (zh) * | 2022-10-18 | 2024-05-03 | 杭州汉库医药科技有限公司 | 一种混悬型肺表面活性物质注射液及其制备方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5260273A (en) | 1988-01-06 | 1993-11-09 | The Scripps Research Institute | Pulmonary surfactant protein and related polypeptide |
| US5164369A (en) | 1988-01-06 | 1992-11-17 | The Scripps Research Institute | Pulmonary surfactant protein and related polypeptide |
| DE3921954A1 (de) * | 1989-07-04 | 1991-01-17 | Thomae Gmbh Dr K | Niedrig-viskose, hochkonzentrierte surfactant-suspension |
| DE4418936A1 (de) | 1994-05-31 | 1996-02-08 | Byk Gulden Lomberg Chem Fab | Polypeptid |
| GB9524007D0 (en) * | 1995-11-23 | 1996-01-24 | Bangham Alec D | Endotrachael tubes with pulmonary medicaments |
| IT1308180B1 (it) | 1999-02-12 | 2001-12-07 | Chiesi Farma Spa | Peptidi sintetici aventi la capacita' di diminuire la tensionesuperficiale e loro impiego nella preparazione di un surfattante |
| WO2003035679A2 (en) * | 2001-10-25 | 2003-05-01 | Medical Research Council | Molecules |
| EP1897577B1 (de) * | 2002-08-02 | 2012-05-16 | Med In Medical Innovations GmbH | Vorrichtung zur Erzeugung eines kontinuierlichen positiven Atemwegdrucks (CPAP-Vorrichtung) |
| US20060040860A1 (en) * | 2004-06-17 | 2006-02-23 | Mario Ruediger | Intra-tracheal application of vascular endothelial growth factor (VEGF) for the prevention of lung damages caused by hperoxia |
| US20060112961A1 (en) * | 2004-11-29 | 2006-06-01 | Hany Aly | Pediatric mask, especially suited for premature infants |
| ES2380046T3 (es) * | 2005-01-06 | 2012-05-08 | Discovery Laboratories, Inc. | Régimen para el tratamiento con tensioactivos para tratar o prevenir la displasia broncopulmonar |
-
2007
- 2007-06-08 US US11/811,351 patent/US8048043B2/en active Active
-
2008
- 2008-05-23 ES ES08758716.8T patent/ES2547489T3/es active Active
- 2008-05-23 MX MX2013006282A patent/MX359316B/es unknown
- 2008-05-23 CN CN2008800167252A patent/CN101765431B/zh active Active
- 2008-05-23 MX MX2009012835A patent/MX2009012835A/es not_active Application Discontinuation
- 2008-05-23 HU HUE08758716A patent/HUE025957T2/en unknown
- 2008-05-23 WO PCT/EP2008/004120 patent/WO2008148469A1/en active Application Filing
- 2008-05-23 PL PL08758716T patent/PL2164504T3/pl unknown
- 2008-05-23 HU HUE14150705A patent/HUE031750T2/en unknown
- 2008-05-23 SI SI200831485T patent/SI2164504T1/sl unknown
- 2008-05-23 ME MEP-2016-21A patent/ME02327B/me unknown
- 2008-05-23 AU AU2008258872A patent/AU2008258872B2/en active Active
- 2008-05-23 BR BRPI0811387A patent/BRPI0811387B8/pt active IP Right Grant
- 2008-05-23 LT LTEP14150705.3T patent/LT2719391T/lt unknown
- 2008-05-23 PT PT141507053T patent/PT2719391T/pt unknown
- 2008-05-23 KR KR1020097022778A patent/KR101344159B1/ko active IP Right Grant
- 2008-05-23 SI SI200831761A patent/SI2719391T1/sl unknown
- 2008-05-23 EA EA200901499A patent/EA016308B1/ru not_active IP Right Cessation
- 2008-05-23 PT PT87587168T patent/PT2164504E/pt unknown
- 2008-05-23 EP EP08758716.8A patent/EP2164504B1/en active Active
- 2008-05-23 DK DK08758716.8T patent/DK2164504T3/en active
- 2008-05-23 CA CA2690097A patent/CA2690097C/en active Active
- 2008-05-23 ES ES14150705.3T patent/ES2616727T3/es active Active
- 2008-05-23 RS RS20150558A patent/RS54196B1/en unknown
- 2008-05-23 RS RS20170162A patent/RS55733B1/sr unknown
- 2008-05-23 JP JP2010510665A patent/JP5490683B2/ja active Active
- 2008-05-23 EP EP14150705.3A patent/EP2719391B1/en active Active
- 2008-05-23 PL PL14150705T patent/PL2719391T3/pl unknown
- 2008-05-23 KR KR1020137005157A patent/KR101399738B1/ko active IP Right Grant
- 2008-05-23 DK DK14150705.3T patent/DK2719391T3/en active
-
2010
- 2010-08-20 HK HK10107979.8A patent/HK1141457A1/xx unknown
-
2011
- 2011-10-04 US US13/252,532 patent/US8905979B2/en active Active
-
2015
- 2015-09-09 CY CY20151100781T patent/CY1116680T1/el unknown
- 2015-09-14 HR HRP20150966TT patent/HRP20150966T1/hr unknown
-
2017
- 2017-02-15 CY CY20171100201T patent/CY1118635T1/el unknown
- 2017-02-21 HR HRP20170270TT patent/HRP20170270T1/hr unknown
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