DK2393477T3 - Anvendelse af en glucocorticoidsammensætning til behandling af svær og ukontrolleret astma - Google Patents
Anvendelse af en glucocorticoidsammensætning til behandling af svær og ukontrolleret astma Download PDFInfo
- Publication number
- DK2393477T3 DK2393477T3 DK10705986.7T DK10705986T DK2393477T3 DK 2393477 T3 DK2393477 T3 DK 2393477T3 DK 10705986 T DK10705986 T DK 10705986T DK 2393477 T3 DK2393477 T3 DK 2393477T3
- Authority
- DK
- Denmark
- Prior art keywords
- inhalation
- approx
- aerosol
- composition
- patient
- Prior art date
Links
Classifications
-
- 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
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
-
- 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
- A61P11/06—Antiasthmatics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Dispersion Chemistry (AREA)
- Otolaryngology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. Inhalerbar glucocorticoidsammensætning til anvendelse ved behandling af en patient, som har svær og ukontrolleret astma, hvor sammensætningen administreres som en forstøvet aerosol, der frembringes af en inhalationsanordning, hvilken anordning er tilpasset til (a) at udsende den forstøvede aerosol i patientens inhalationsfase ved en hastighed på ikke over ca. 20 liter pr. minut; (b) at udsende et totalvolumen pr. inhalationsfase på mindst ca. 0,4 liter gasfase, hvilken gasfase indbefatter forstøvet aerosol og eventuelt aerosolfri luft; og (c) at udsende ikke over ca. 150 milliliter aerosolfri luft pr. inhalationsfase før udsendelse af forstøvet aerosol, forudsat at sammensætningen ikke omfatter methylxanthin.
2. Inhalerbar glucocorticoidsammensætning til anvendelse ifølge krav 1, hvor glucocorticoidet er valgt blandt fluticasonpropionat, budesonid, beclomethasondipropionat, ciclesonid, flunisolid, mometasonfuroat og triamcinolonacetonid.
3. Sammensætning til anvendelse ifølge krav 1 eller 2, hvor behandlingen endvidere indbefatter oral administration af et oralt glucocorticoid i en daglig dosis, som ikke er højere end ca. 40 milligram prednisolon eller en ækvipotent dosis af et andet glucocorticoid.
4. Sammensætning til anvendelse ifølge krav 3, hvor det oralt administrerede glucocorticoid er valgt blandt hydrocortison, dexamethason, prednison, prednisolon og methylprednisolon.
5. Sammensætning til anvendelse ifølge krav 3 eller 4, hvor den daglige dosis af det oralt administrerede glucocorticoid reduceres under behandlingen med mindst 30% i forhold til den indledende daglige dosis.
6. Sammensætning til anvendelse ifølge krav 3 eller 4, hvor den daglige dosis af det oralt administrerede glucocorticoid reduceres til nul under behandlingen.
7. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at udsende et gasfase-totalvolumen pr. inhalationsfase i intervallet fra ca. 0,4 til ca. 2 liter, og fortrinsvis fra ca. 0,4 til ca. 1,4 liter, hvilket totalvolumen er valgt på grundlag af patientens inhalationskapacitet eller patientens faktiske og forudsagte forcerede eksspirationsvolumen på ét sekund.
8. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at frembringe en forstøvet aerosol med en aerodynamisk massemedian-diameter (mass median aerodynamic diameter - MMAD) fra ca. 2 til ca. 6 mikrometer, og fortrinsvis fra ca. 3 til ca. 5 mikrometer.
9. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at udsende den forstøvede aerosol i patientens inhalationsfase ved et overtryk på op til ca. 40 mbar.
10. Sammensætning til anvendelse ifølge krav 9, hvor overtrykket i inhalationsfasen i alt væsentligt holdes på mindst ca. 1 mbar.
11. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til kun at udsende gasfase efter at være blevet åndedrætsaktiveret af patienten.
12. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at udsende fra ca. 200 til ca. 3.000 milliliter forstøvet aerosol pr. inhalationsfase.
13. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at udsende fra ca. 200 til ca. 500 milliliter aerosolfri luft, efter udsendelse af den forstøvede aerosol, pr. inhalationsfase.
14. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor inhalationsanordningen er tilpasset til at udsende den forstøvede aerosol ved en hastighed på ikke over ca. 300 milliliter pr. sekund, og fortrinsvis ikke over 250 milliliter pr. sekund.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12/365,754 US20100196483A1 (en) | 2009-02-04 | 2009-02-04 | Method for treatmentof severe and uncontrollable asthma |
| PCT/EP2010/051321 WO2010089330A1 (en) | 2009-02-04 | 2010-02-03 | Use of a glucocorticoid composition for the treatment of severe and uncontrolled asthma |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2393477T3 true DK2393477T3 (da) | 2018-04-09 |
Family
ID=42153807
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10705986.7T DK2393477T3 (da) | 2009-02-04 | 2010-02-03 | Anvendelse af en glucocorticoidsammensætning til behandling af svær og ukontrolleret astma |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US20100196483A1 (da) |
| EP (2) | EP3338782A1 (da) |
| JP (1) | JP5886630B2 (da) |
| KR (1) | KR20110122671A (da) |
| CN (2) | CN104306360A (da) |
| AU (1) | AU2010210183B2 (da) |
| BR (1) | BRPI1008227A8 (da) |
| CA (1) | CA2751443C (da) |
| DK (1) | DK2393477T3 (da) |
| ES (1) | ES2659328T3 (da) |
| HU (1) | HUE038553T2 (da) |
| IL (1) | IL213959A (da) |
| MX (1) | MX2011008200A (da) |
| NO (1) | NO2393477T3 (da) |
| NZ (1) | NZ594210A (da) |
| PL (1) | PL2393477T3 (da) |
| PT (1) | PT2393477T (da) |
| RU (1) | RU2519344C2 (da) |
| SG (1) | SG173538A1 (da) |
| SI (1) | SI2393477T1 (da) |
| UA (1) | UA102587C2 (da) |
| WO (1) | WO2010089330A1 (da) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2230934B8 (en) | 2007-12-14 | 2012-10-24 | AeroDesigns, Inc | Delivering aerosolizable food products |
| PL2846859T3 (pl) | 2012-03-09 | 2017-07-31 | Vectura Gmbh | Kanał mieszania do urządzenia do inhalacji i urządzenie do inhalacji |
| WO2014012954A1 (en) * | 2012-07-18 | 2014-01-23 | Takeda Gmbh | Treatment of partly controlled or uncontrolled severe asthma |
| US20140261474A1 (en) * | 2013-03-15 | 2014-09-18 | Aradigm Corporation | Methods for inhalation of smoke-free nicotine |
| US8807131B1 (en) | 2013-06-18 | 2014-08-19 | Isonea Limited | Compliance monitoring for asthma inhalers |
| US10307370B2 (en) | 2013-10-08 | 2019-06-04 | AI Therapeutics, Inc. | Rapamycin for the treatment of lymphangioleiomyomatosis |
| JP2017503814A (ja) * | 2014-01-22 | 2017-02-02 | タケダ ゲー・エム・ベー・ハーＴａｋｅｄａ ＧｍｂＨ | 部分的コントロール状態の重症喘息またはコントロール不良状態の重症喘息のｐｄｅ４インヒビターを用いた（およびロイコトリエン調節薬と組み合わせて用いた）治療 |
| HUE062742T2 (hu) * | 2014-04-04 | 2023-12-28 | Ai Therapeutics Inc | Belélegezhetõ rapamicin készítmény életkorral kapcsolatos állapotok kezelésére |
| CA2953207A1 (en) * | 2014-06-25 | 2015-12-30 | Optinose As | Nasal administration |
| MX2017004440A (es) | 2014-10-07 | 2017-11-01 | Lam Therapeutics Inc | Una formulacion de rapamicina inhalable para el tratamiento de hipertension pulmonar. |
| RU2611406C1 (ru) * | 2015-09-03 | 2017-02-21 | Общество с ограниченной ответственностью "Биосурф" (ООО "Биосурф") | Способ лечения бронхиальной астмы |
| EP3984579A1 (en) | 2016-07-08 | 2022-04-20 | Trudell Medical International | Smart oscillating positive expiratory pressure device |
| US11497867B2 (en) | 2016-12-09 | 2022-11-15 | Trudell Medical International | Smart nebulizer |
| MX2020007026A (es) | 2018-01-04 | 2020-12-03 | Trudell Medical Int | Dispositivo de presión espiratoria positiva oscilante inteligente. |
| WO2021038467A1 (en) | 2019-08-27 | 2021-03-04 | Trudell Medical International | Smart oscillating positive expiratory pressure device |
| US11593679B2 (en) * | 2019-11-29 | 2023-02-28 | Kpn Innovations, Llc. | Method of and system for generating a longevity element and an instruction set for a longevity element plan |
| US20220246260A1 (en) * | 2021-01-29 | 2022-08-04 | AsthmaTek, Inc. | Systems and methods to determine a therapy regimen to treat asthma of a subject |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19720701A1 (de) * | 1997-05-16 | 1998-11-19 | Gsf Forschungszentrum Umwelt | Vorrichtung zur Applikation eines Medikament-Aerosols über die Lunge |
| US6187765B1 (en) * | 1997-10-09 | 2001-02-13 | Schering Corporation | Mometasone furoate suspensions for nebulization |
| DE19851279B4 (de) * | 1998-06-17 | 2006-05-24 | GSF - Forschungszentrum für Umwelt und Gesundheit GmbH | Vorrichtung zum gesteuerten inhalatorischen Einbringen von dosierten Medikamenten in die Lunge |
| DE19912265A1 (de) * | 1999-03-18 | 2000-09-21 | Gsf Forschungszentrum Umwelt | Verfahren und Vorrichtung zur Bereitstellung einer konstanten Medikamenten-Dosis für eine inhalatorische Applikation mit niedrigem Inhalationsfluß |
| DE19912461B4 (de) * | 1999-03-19 | 2006-07-20 | GSF - Forschungszentrum für Umwelt und Gesundheit GmbH | Vorrichtung zur Flußbegrenzung bei niedrigen Differenzdrücken |
| DE10013093B4 (de) * | 2000-03-17 | 2005-12-22 | Inamed Gmbh | Vorrichtung zur kontrollierten Inhalation therapeutischer Aerosole |
| DE10029119B4 (de) * | 2000-06-14 | 2005-12-22 | Institut für Aerosol Medizin InAMed GmbH | Inhalationsvorrichtung |
| DE10123749A1 (de) * | 2001-05-16 | 2002-12-12 | Inamed Gmbh | Vorrichtung zum Verabreichen von Aerosolen |
| US20070020299A1 (en) * | 2003-12-31 | 2007-01-25 | Pipkin James D | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
| EP1729724A4 (en) * | 2003-12-31 | 2008-07-23 | Cydex Inc | INHALATION FORMULATION WITH SULFOALKYL ETHER GAMMA CYCLODEXTRIN AND CORTICOSTEROID |
| EP1700614B1 (de) * | 2005-03-08 | 2013-05-08 | Activaero GmbH | Inhalationsvorrichtung |
| EP1741460B1 (de) * | 2005-07-06 | 2007-09-19 | Activaero GmbH | Regelbares Ventil und Inhalationsvorrichtung |
| KR100802292B1 (ko) * | 2006-07-21 | 2008-02-11 | 동부일렉트로닉스 주식회사 | 마스크 및 이를 이용한 마이크로 렌즈 제작 방법 |
| EP2173169B1 (en) * | 2007-06-28 | 2014-05-21 | CyDex Pharmaceuticals, Inc. | Nasal delivery of aqueous corticosteroid solutions |
| CA2740360A1 (en) * | 2008-10-14 | 2010-04-22 | Activaero Gmbh | Method for treatment of copd and other pulmonary diseases |
-
2009
- 2009-02-04 US US12/365,754 patent/US20100196483A1/en not_active Abandoned
-
2010
- 2010-02-03 UA UAA201110621A patent/UA102587C2/ru unknown
- 2010-02-03 NO NO10705986A patent/NO2393477T3/no unknown
- 2010-02-03 NZ NZ594210A patent/NZ594210A/xx unknown
- 2010-02-03 MX MX2011008200A patent/MX2011008200A/es active IP Right Grant
- 2010-02-03 AU AU2010210183A patent/AU2010210183B2/en active Active
- 2010-02-03 CN CN201410371150.3A patent/CN104306360A/zh active Pending
- 2010-02-03 HU HUE10705986A patent/HUE038553T2/hu unknown
- 2010-02-03 JP JP2011548677A patent/JP5886630B2/ja active Active
- 2010-02-03 SI SI201031650T patent/SI2393477T1/en unknown
- 2010-02-03 WO PCT/EP2010/051321 patent/WO2010089330A1/en active Application Filing
- 2010-02-03 SG SG2011056207A patent/SG173538A1/en unknown
- 2010-02-03 EP EP17206605.2A patent/EP3338782A1/en active Pending
- 2010-02-03 CA CA2751443A patent/CA2751443C/en active Active
- 2010-02-03 RU RU2011135824/15A patent/RU2519344C2/ru active
- 2010-02-03 KR KR1020117017903A patent/KR20110122671A/ko active Search and Examination
- 2010-02-03 CN CN201080006616XA patent/CN102307567A/zh active Pending
- 2010-02-03 ES ES10705986.7T patent/ES2659328T3/es active Active
- 2010-02-03 DK DK10705986.7T patent/DK2393477T3/da active
- 2010-02-03 EP EP10705986.7A patent/EP2393477B1/en not_active Revoked
- 2010-02-03 BR BRPI1008227A patent/BRPI1008227A8/pt not_active Application Discontinuation
- 2010-02-03 PT PT107059867T patent/PT2393477T/pt unknown
- 2010-02-03 PL PL10705986T patent/PL2393477T3/pl unknown
-
2011
- 2011-07-06 IL IL213959A patent/IL213959A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| UA102587C2 (ru) | 2013-07-25 |
| BRPI1008227A8 (pt) | 2018-12-11 |
| KR20110122671A (ko) | 2011-11-10 |
| JP5886630B2 (ja) | 2016-03-16 |
| IL213959A0 (en) | 2011-08-31 |
| AU2010210183B2 (en) | 2014-09-11 |
| CA2751443A1 (en) | 2010-08-12 |
| MX2011008200A (es) | 2011-10-21 |
| US20100196483A1 (en) | 2010-08-05 |
| SI2393477T1 (en) | 2018-04-30 |
| PT2393477T (pt) | 2018-02-14 |
| WO2010089330A1 (en) | 2010-08-12 |
| RU2519344C2 (ru) | 2014-06-10 |
| CN102307567A (zh) | 2012-01-04 |
| CN104306360A (zh) | 2015-01-28 |
| RU2011135824A (ru) | 2013-03-10 |
| JP2012516873A (ja) | 2012-07-26 |
| AU2010210183A1 (en) | 2011-07-28 |
| CA2751443C (en) | 2018-03-20 |
| SG173538A1 (en) | 2011-09-29 |
| EP3338782A1 (en) | 2018-06-27 |
| NO2393477T3 (da) | 2018-05-26 |
| EP2393477A1 (en) | 2011-12-14 |
| ES2659328T3 (es) | 2018-03-14 |
| EP2393477B1 (en) | 2017-12-27 |
| HUE038553T2 (hu) | 2018-10-29 |
| IL213959A (en) | 2015-05-31 |
| BRPI1008227A2 (pt) | 2016-03-08 |
| NZ594210A (en) | 2013-09-27 |
| PL2393477T3 (pl) | 2018-06-29 |
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