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.)
- Active
Links
- 239000003580 lung surfactant Substances 0.000 title abstract 2
- 238000000034 method Methods 0.000 title description 4
- 210000003437 trachea Anatomy 0.000 abstract description 2
- 238000011282 treatment Methods 0.000 abstract description 2
- 239000012736 aqueous medium Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- 239000000523 sample Substances 0.000 abstract 1
- 208000011580 syndromic disease Diseases 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 description 4
- 238000002627 tracheal intubation Methods 0.000 description 4
- 206010051606 Necrotising colitis Diseases 0.000 description 2
- 208000017442 Retinal disease Diseases 0.000 description 2
- 206010038923 Retinopathy Diseases 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 208000004995 necrotizing enterocolitis Diseases 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 201000006195 perinatal necrotizing enterocolitis Diseases 0.000 description 2
- 238000009423 ventilation Methods 0.000 description 2
- 206010036590 Premature baby Diseases 0.000 description 1
- 206010038687 Respiratory distress Diseases 0.000 description 1
- 206010066901 Treatment failure Diseases 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 208000003906 hydrocephalus Diseases 0.000 description 1
- 206010022694 intestinal perforation Diseases 0.000 description 1
- 238000005399 mechanical ventilation Methods 0.000 description 1
- 208000003278 patent ductus arteriosus Diseases 0.000 description 1
- 201000003144 pneumothorax Diseases 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
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)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (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 (22)
| Country | Link |
|---|---|
| US (2) | US8048043B2 (es) |
| EP (2) | EP2719391B1 (es) |
| JP (1) | JP5490683B2 (es) |
| KR (2) | KR101399738B1 (es) |
| CN (1) | CN101765431B (es) |
| AU (1) | AU2008258872B2 (es) |
| BR (1) | BRPI0811387B8 (es) |
| CA (1) | CA2690097C (es) |
| CY (2) | CY1116680T1 (es) |
| DK (2) | DK2719391T3 (es) |
| EA (1) | EA016308B1 (es) |
| ES (2) | ES2547489T3 (es) |
| HR (2) | HRP20150966T1 (es) |
| HU (2) | HUE031750T2 (es) |
| LT (1) | LT2719391T (es) |
| ME (1) | ME02327B (es) |
| MX (2) | MX2009012835A (es) |
| PL (2) | PL2719391T3 (es) |
| PT (2) | PT2719391T (es) |
| RS (2) | RS55733B1 (es) |
| SI (2) | SI2164504T1 (es) |
| WO (1) | WO2008148469A1 (es) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011029525A1 (en) | 2009-09-08 | 2011-03-17 | 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 |
| EP4186548A1 (en) | 2015-04-02 | 2023-05-31 | Hill-Rom Services PTE. LTD. | Mask leakage detection for a 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 |
| CN109890446B (zh) | 2016-10-26 | 2022-03-22 | 奇斯药制品公司 | 用于帮助通过导管向肺给送药剂的装置 |
| CA3043792A1 (en) | 2016-12-22 | 2018-06-28 | Chiesi Farmaceutici S.P.A. | A therapeutic combination comprising a pulmonary surfactant and a steroid for the treatment of evolving bpd |
| JP7378425B2 (ja) | 2018-04-23 | 2023-11-13 | シエシー ファルマセウティチィ ソシエタ ペル アチオニ | 肺サーファクタントおよびｂｐｄの予防のためのステロイドを含む治療的組合せ |
| CN113164701B (zh) | 2018-12-06 | 2024-07-12 | 奇斯药制品公司 | 喉罩气道装置和通过喉罩气道装置给药的方法 |
| US11219843B2 (en) * | 2019-07-08 | 2022-01-11 | Nik Paya Karen Pharmed | Extraction of animal-derived pulmonary surfactants |
| US20230257446A1 (en) | 2020-01-28 | 2023-08-17 | Chiesi Farmaceutici S.P.A. | Polypeptides having improved properties |
| WO2023280737A1 (en) * | 2021-07-05 | 2023-01-12 | 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 |
| EP1386631A1 (de) * | 2002-08-02 | 2004-02-04 | MED IN Medical Innovations Vetriebs 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 |
| SI1841458T1 (sl) * | 2005-01-06 | 2012-04-30 | Discovery Lab Inc | Zdravljenje s predpisanim odmerjanjem surfaktanta za zdravljenje ali preprečevanje bronhopulmonalne displazije |
-
2007
- 2007-06-08 US US11/811,351 patent/US8048043B2/en active Active
-
2008
- 2008-05-23 PL PL14150705T patent/PL2719391T3/pl unknown
- 2008-05-23 EP EP14150705.3A patent/EP2719391B1/en active Active
- 2008-05-23 KR KR1020137005157A patent/KR101399738B1/ko active Active
- 2008-05-23 HR HRP20150966TT patent/HRP20150966T1/hr unknown
- 2008-05-23 ES ES08758716.8T patent/ES2547489T3/es active Active
- 2008-05-23 WO PCT/EP2008/004120 patent/WO2008148469A1/en not_active Ceased
- 2008-05-23 ES ES14150705.3T patent/ES2616727T3/es active Active
- 2008-05-23 PT PT141507053T patent/PT2719391T/pt unknown
- 2008-05-23 RS RS20170162A patent/RS55733B1/sr unknown
- 2008-05-23 KR KR1020097022778A patent/KR101344159B1/ko active Active
- 2008-05-23 EA EA200901499A patent/EA016308B1/ru not_active IP Right Cessation
- 2008-05-23 RS RS20150558A patent/RS54196B1/sr unknown
- 2008-05-23 PT PT87587168T patent/PT2164504E/pt unknown
- 2008-05-23 SI SI200831485T patent/SI2164504T1/sl unknown
- 2008-05-23 MX MX2009012835A patent/MX2009012835A/es not_active Application Discontinuation
- 2008-05-23 JP JP2010510665A patent/JP5490683B2/ja active Active
- 2008-05-23 PL PL08758716T patent/PL2164504T3/pl unknown
- 2008-05-23 SI SI200831761A patent/SI2719391T1/sl unknown
- 2008-05-23 ME MEP-2016-21A patent/ME02327B/me unknown
- 2008-05-23 MX MX2013006282A patent/MX359316B/es unknown
- 2008-05-23 LT LTEP14150705.3T patent/LT2719391T/lt unknown
- 2008-05-23 HU HUE14150705A patent/HUE031750T2/en unknown
- 2008-05-23 BR BRPI0811387A patent/BRPI0811387B8/pt active IP Right Grant
- 2008-05-23 AU AU2008258872A patent/AU2008258872B2/en active Active
- 2008-05-23 HU HUE08758716A patent/HUE025957T2/en unknown
- 2008-05-23 CA CA2690097A patent/CA2690097C/en active Active
- 2008-05-23 DK DK14150705.3T patent/DK2719391T3/en active
- 2008-05-23 DK DK08758716.8T patent/DK2164504T3/en active
- 2008-05-23 CN CN2008800167252A patent/CN101765431B/zh active Active
- 2008-05-23 EP EP08758716.8A patent/EP2164504B1/en active Active
-
2011
- 2011-10-04 US US13/252,532 patent/US8905979B2/en active Active
-
2015
- 2015-09-09 CY CY20151100781T patent/CY1116680T1/el unknown
-
2017
- 2017-02-15 CY CY20171100201T patent/CY1118635T1/el unknown
- 2017-02-21 HR HRP20170270TT patent/HRP20170270T1/hr unknown
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