Испытание одежды на клещей у детей

Название протокола
Клинические исследование Allergic Rhinitis Due to Dermatophagoides Farinae: Sublingual allergy immunotherapy tablet, Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: ALK-Abelló A/S

Источник ALK-Abelló A/S
Краткое содержание

Исследование действия таблеток от клещей пыли по сравнению с плацебо у детей в возрасте в возрасте от 5 до 11 лет с выявлением кожно-клещевой пыльцы (MATIC)

Подробное описание

Испытание направленности на то, чтобы повысить эффективность SLIT-таблеток от клещей пыли по сравнению с плацебо. у детей (5-11 лет) с аллергическим ринитом, избирательным клещами пыли, в расчете на окружающую среду комбинированные симптомы ринита и оценка медикаментозного лечения в течение последних 8 недель лечения. Кроме того, в ходе исследования будут оцениваться безопасность и переносимость лечения, а также выявление симптомов астмы и прием лекарств, иммунологический параметры и качество жизни (КЖ) при риноконъюнктивите. Исследование представляет собой рандомизированное, двойное слепое, плацебо-контролируемое многонациональное исследование с пропорциональными измерениями. фаза III, проведенная в Европе и Европе. Срок лечения будет примерно 1 год.

Общий статус Рекрутинг
Дата начала 2019-10-12
Дата завершения 2023-04-01
Дата первичного завершения 2023-04-01
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Комбинированные симптомы ринита и медикаментозное лечение Последние 8 недель из примерно 12 месяцев лечения
Вторичный результат
Мера Временное ограничение
Rhinitis symptoms The last 8 weeks of approximately 12 months of treatment
Лекарство от ринита Последние 8 недель из примерно 12 месяцев лечения
Комбинированные симптомы риноконъюнктивита и медикаментозное лечение Последние 8 недель из примерно 12 месяцев лечения
Безопасность и переносимость От первого проверенного субъекта до последнего субъекта при последнем посещении
Регистрация 1370
Состояние
  • Allergic Rhinitis Due to Dermatophagoides Farinae
  • Аллергический ринит, вызванный Dermatophagoides Pteronyssinus
  • Аллергический ринит, вызванный клещом пылеобразования
Вмешательство

Тип вмешательства: Biological

Название вмешательства: Sublingual allergy immunotherapy tablet

Описание: For daily administration (1 tablet per day)

Этикетка Arm Group: Active treatment

Тип вмешательства: Другой

Название вмешательства: Плацебо

Описание: Для ежедневного приема (1 таблетка в день)

Этикетка Arm Group: Плацебо

Другое имя: Плацебо сублингвальная таблетка

Приемлемость

Критерии:

Критерии включения: - Испытуемые мужского или женского пола в возрасте 5-11 лет - Клинический анамнез HDM AR/C (с астмой или без нее) и с аллергическим ринитом симптомы, несмотря на то, что в течение предыдущего года получали фармакотерапию от аллергии до скрининга - Иметь определенный уровень симптомов АР как минимум в течение 8 из последних 14 дней исходного уровня период - Используйте симптоматические препараты для лечения аллергического ринита HDM в течение не менее 8 дней. последние 14 дней базового периода - Положительный кожный прик-тест (КПТ) и IgE к D. pteronyssinus или D. farinae при скрининге - Функция легких ≥ 70% от прогнозируемого значения Критерий исключения: - Сенсибилизированные и регулярно подвергающиеся воздействию круглогодичных аллергенов - Любое заболевание носа или глотки, которое может повлиять на безопасность или эффективность оценка - Астма, требующая лечения высокими дозами ингаляционных кортикостероидов - Соответствующая история системной аллергической реакции

Пол:

Все

Минимальный возраст:

5 лет

Максимальный возраст:

11 лет

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Antje Schuster, MD Principal Investigator Professor of Pediatrics, Düsseldorf University Hospital
Общий контакт

Фамилия: Dorthe Thrane, MSc

Телефон: +45 45747576

Расположение
Объект: Положение дел: Контакт:
Clinical research center of Alabama | Birmingham, Alabama, 35244, United States Recruiting Sikora, MD
Atria Clinical Research | Little Rock, Arkansas, 72209, United States Recruiting Badhwar, MD
Kern Research, Inc | Bakersfield, California, 93301, United States Recruiting Tanus, MD
Allergy & Asthma Specialists Medical Group and Research Center | Huntington Beach, California, 92647, United States Recruiting Weinstein, MD
Antelope Valley Clinical Trials | Lancaster, California, 93534, United States Recruiting Perez, MD
Ark Clinical Research | Long Beach, California, 90806, United States Recruiting Kim, MD
California Allergy and Asthma Medical Group | Los Angeles, California, 90025, United States Recruiting Ricardo Tan, MD Principal Investigator
Allergy & Asthma Medical Group and Research Center, A P.C. | San Diego, California, 92123, United States Recruiting Greiner, MD
Medical Research Centre of Maimi ll, Inc. | Miami, Florida, 33134, United States Recruiting Cancio Vega, MD
Miami Clinical Research | Miami, Florida, 33155, United States Recruiting Hoover, MD
C'A Research, LLC | Miami, Florida, 33174, United States Recruiting Sirven, MD
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center | Pensacola, Florida, 32503, United States Recruiting Reese, MD
GCP, Global Clinical Professionals | Saint Petersburg, Florida, 33705, United States Recruiting Stoici, MD
Sarasota Clinical Research | Sarasota, Florida, 34239, United States Recruiting Windom, MD
University of South Florida Asthma, Allergy and Immunology | Tampa, Florida, 33613, United States Recruiting Lockey, MD
Atlanta Allergy & Asthma Clinic, PA | Marietta, Georgia, 30060, United States Recruiting Fineman, MD
Omega Pediatrics and Weight Loss | Roswell, Georgia, 30076, United States Recruiting Nwaneri, MD
Aeroallergy Research Labs of Savannah, Inc. | Savannah, Georgia, 31406, United States Recruiting Finkel, MD
Clinical Research Atlanta | Stockbridge, Georgia, 30281, United States Recruiting Finley, MD
Rush University Medical Center | Chicago, Illinois, 60612, United States Recruiting Moy, MD
Deaconess Clinic Allergy | Evansville, Indiana, 47715, United States Recruiting Koleilat, MD
PMG Research of McFarland Clinic | Ames, Iowa, 50010, United States Recruiting Brown, MD
Bluegrass Allergy Research | Lexington, Kentucky, 40509, United States Recruiting Greisner, MD
Allergy, Asthma & Immunology | Lexington, Kentucky, 40513, United States Recruiting McCafferty, MD
Institute for asthma and allergy | Chevy Chase, Maryland, 20815, United States Recruiting Li, MD
Clinical Research Institute | Minneapolis, Minnesota, 55402, United States Recruiting Mehta, MD
University of Missouri | Columbia, Missouri, 65201, United States Recruiting Franzese, MD
Clinical Research of The Ozarks Inc | Warrensburg, Missouri, 64093, United States Recruiting Landwehr, MD
Summit Medical Group | Berkeley Heights, New Jersey, 07922, United States Recruiting LeBenger, MD
Allergy & Asthma Associates of Monmouth City | Little Silver, New Jersey, 07739, United States Recruiting Zecca, MD
Atlantic Research Center, LLC | Ocean City, New Jersey, 07712, United States Recruiting Sher, MD
Rochester Regional Health | Rochester, New York, 14607, United States Recruiting Mustafa, MD
Allergy Partners of Western North Carolina | Asheville, North Carolina, 28801, United States Recruiting Cypcar, MD
The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital | Chapel Hill, North Carolina, 27599, United States Recruiting Hernandez, MD
UNC Children's Raleigh | Raleigh, North Carolina, 27607, United States Recruiting Hernandez, MD
PMG Research of PHC | Statesville, North Carolina, 28677, United States Recruiting Lichtenberger, MD
Bernstein Clinical Research Center | Cincinnati, Ohio, 45231, United States Recruiting Bernstein, MD
Ohio Clinical Research Associates, Inc. | Mayfield Heights, Ohio, 44124, United States Recruiting Jhaveri, MD
Allergy, Asthma & Clinical Research Center | Oklahoma City, Oklahoma, 73120, United States Recruiting Tarpay, MD
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC | Oklahoma City, Oklahoma, 73131, United States Recruiting Darter, MD
Vital Prospects Clinical Research Institute, P.C. | Tulsa, Oklahoma, 74136, United States Recruiting Hussain, MD
The Corvallis Clinic | Corvallis, Oregon, 97330, United States Recruiting Solensky, MD
West Ashley office: Charleston Allergy & Asthma | Charleston, South Carolina, 29414, United States Recruiting Creticos, MD
ADAC Research, PA | Greenville, South Carolina, 29607, United States Recruiting Kao, MD
Charleston Allergy & Asthma | Summerville, South Carolina, 29485, United States Recruiting Tan, MD
AARA Research Center | Dallas, Texas, 75321, United States Recruiting Lumry, MD
Pediatric Associates, LLC | Houston, Texas, 77087, United States Recruiting Yudovich, MD
Biogenics Research Institute | San Antonio, Texas, 78229, United States Recruiting Jacobs, MD
Element Research Group | San Antonio, Texas, 78258, United States Recruiting Dinger, MD
Allergy Asthma Research Institute | Waco, Texas, 76712, United States Recruiting Amar, MD
Allergy, Asthma & Sinus Center, S.C. | Greenfield, Wisconsin, 53228, United States Recruiting Steven, MD
Multiprofile Hospital for active treatment, Department of Pediatrics | Gabrovo, 5300, Bulgaria Recruiting Pashova-Mihova, MD
Multiprofile Hospital for Active Treatment, Department of Pediatrics | Kyustendil, 2500, Bulgaria Recruiting Dimitrova, MD
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv, 4002, Bulgaria Recruiting Bosheva, MD
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD | Plovdiv, Bulgaria Recruiting Silviya Novakova, MD Principal Investigator
Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics | Razgrad, 7200, Bulgaria Recruiting Cholak, MD
Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology | Razgrad, 7200, Bulgaria Recruiting Cholak, MD
Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse | Ruse, 7002, Bulgaria Recruiting Dachev, MD
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics | Sofia, 1407, Bulgaria Recruiting Dimitrov, MD
Sv. Vratch and Sv.Sv. Kuzma i Damian | Sofia, 1408, Bulgaria Recruiting Stoeva, MD
Alitea-Med-Medical-Center | Sofia, 1618, Bulgaria Recruiting Kraeva, MD
Diagnostic-Consultative center Ritam TR | Stara Zagora, 6000, Bulgaria Recruiting Koleva, MD
Halton Pediatric Allergy | Burlington, L7L 6W6, Canada Recruiting Mack, MD
Triple A Lab | Hamilton, L8S 1G5, Canada Recruiting Ohayon, MD
Kingston General Hospital - Division of Allergy & Immunology | Kingston, K7L 2V7, Canada Recruiting Ellis, MD
Cheema Research Inc | Mississauga, L5A 3V4, Canada Recruiting Cheema, MD
CHU Ste-Justine | Montréal, H3T1C5, Canada Recruiting Desroches, MD
The Montreal Children's Hospital | Montréal, H4A 3J1, Canada Recruiting Alizadehfar, MD
Niagara Clinical Research | Niagara Falls, L2G 1J4, Canada Recruiting Alexander, MD
Gordon Sussman Clinical Research, Inc. | North York, Canada Recruiting Gordon Sussman, MD Principal Investigator
Ottawa Allergy Research Corp | Ottawa, K1G 6C6, Canada Recruiting Yang, MD
Clinique spécialisée en allergie de la capitale | Québec, G1V 4W2, Canada Recruiting Gagnon, MD
Hospital for Sick Children | Toronto, M5G 1X8, Canada Recruiting Upton, MD
Joel Liem Medicine Professional Corporation | Windsor, N8X 2G1, Canada Recruiting Liem, MD
Hôpital Morvan - Service de Pédiatrie | Brest, France Recruiting Pierrick Cros, MD Principal Investigator
CHU de Montpellier - Service Pneumologie et Addictologie | Montpellier, 34090, France Recruiting Caimmi, MD
Kinderarztpraxis Bramsche | Bramsche, 49565, Germany Recruiting Mettlich-Lambrecht, MD
HNO praxis - Dr Yury Yarin | Dresden, 01139, Germany Recruiting Yarin, MD
Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin | Düsseldorf, 40235, Germany Recruiting Schuster, MD
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin | Frankfurt, Germany Recruiting Stefan Zielen, MD Principal Investigator
GMAP/HNO am Neckar | Heidelberg, 68120, Germany Recruiting Horn, MD
CD8 klinika | Kaunas, LT-44191, Lithuania Recruiting Staikuniene, MD
Vilnius Centro Outpatient Clinic | Vilnius, LT-01117, Lithuania Recruiting Valatkiene, MD
JSC Seimos gydytojas | Vilnius, LT-01118, Lithuania Recruiting Rudzeviciene, MD
Center of Allergy Diagnosis and Treatment | Vilnius, LT-08109, Lithuania Recruiting Vaiciulioniene, MD
Inlita JSC, Santara KTC | Vilnius, Lithuania Recruiting Kestutis Cerniauskas, MD Principal Investigator
Siauliai Republican Hospital | Šiauliai, LT-76231, Lithuania Recruiting Jadzeviciene, MD
Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz | Gryfice, 72-300, Poland Recruiting Matusz, MD
Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska | Katowice, 40-338, Poland Recruiting Orlicz-Widawska, MD
Centrum Medyczne ALL-MED | Kraków, 30-033, Poland Recruiting Pulka, MD
Centrum Medyczne Plejady | Kraków, 30-363, Poland Recruiting Cichocka-Jarosz, MD
Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk | Lublin, 20-050, Poland Recruiting Emeryk, MD
Centrum Alergologii Teresa Hofman Sp. z o.o. | Poznań, 60-214, Poland Recruiting Hofman, MD
Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o. | Rzeszow, 35-612, Poland Recruiting Rachel, MD
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz | Rzeszów, Poland Recruiting Malgorzata Pawlukiewicz, MD Principal Investigator
IRMED Irena Wojciechowska | Warszawa, 01-157, Poland Recruiting Wojciechowska, MD
All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel | Wrocław, 53-201, Poland Recruiting Jutel, MD
Poradnia Alergologiczna | Łódź, 90-141, Poland Recruiting Kuna, MD
Poradnia Alergologiczna | Łódź, 90-329, Poland Recruiting Brzozowska, MD
City Children's Hospital | Kolpino, 196657, Russian Federation Recruiting Laleko, MD
Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University | Krasnoyarsk, 660022, Russian Federation Recruiting Ilenkova, MD
NRC Institute of Immunology | Moscow, 115478, Russian Federation Recruiting Nazarova, MD
Moscow City Children's Hospital No 9 | Moscow, 123317, Russian Federation Recruiting Krapivkin, MD
City Сhildren's Сlinical Polyclinic No5 | Perm, 614066, Russian Federation Recruiting Perminova, MD
Rostov-on-Don Clinical Diagnostic Center Zdorovie | Rostov-on-Don, 344002, Russian Federation Recruiting Sarychev, MD
I.P. Pavlov Ryazan State Medical University | Ryazan', 390026, Russian Federation Recruiting Dmitriev, MD
Medical Technologies" Ltd. | Saint Petersburg, 191025, Russian Federation Recruiting Galustyan, MD
City Children's Polyclinic No44 | Saint Petersburg, 191144, Russian Federation Recruiting Trusova, MD
ArsVitae Severo-Zapad LLC | Saint Petersburg, 194223, Russian Federation Recruiting Lazareva, MD
North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation | Saint Petersburg, 194291, Russian Federation Recruiting Klimko, MD
Сurator LLC | Saint Petersburg, 196240, Russian Federation Recruiting Soroka, MD
City Children's Polyclinic No45 | Saint Petersburg, Russian Federation Recruiting Nezabudkina, MD
Сity Children's Polyclinic No 35 | Saint Petersburg, Russian Federation Recruiting Tatiana Antonova, MD Principal Investigator
Samara State Medical University | Samara, 443079, Russian Federation Recruiting Zhestkov, MD
Smolensk State Medical University | Smolensk, 214019, Russian Federation Recruiting Meshkova, MD
Scientific Medical Center for General Therapy and Pharmacology | Stavropol', 355000, Russian Federation Recruiting Ukhanova, MD
Regional Children's Hospital | Tomsk, 634009, Russian Federation Recruiting Kamaltynova, MD
Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie | Košice, Slovakia Recruiting Daniela Safcakova, MD Principal Investigator
Ambulancia klinickej imunologie a alergologie | Levice, 93501, Slovakia Recruiting Lapsanska, MD
ALFA EL, Imunoalergologická ambulancia | Poprad, 05801, Slovakia Recruiting Mikler, MD
Ambulancia klinickej imunologie a alergologie | Šurany, 94201, Slovakia Recruiting Hajdenova, MD
Hospital Vall d'Hebron | Barcelona, 08035, Spain Recruiting Garriga Baraut, MD
Hospital Sant Joan de Deu | Esplugues De Llobregat, 08950, Spain Recruiting Piquer Gibert, MD
Hospital Universitario de Jerez de la Frontera | Jerez De La Frontera, 11407, Spain Recruiting Gómez-Pastrana, MD
Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria, 35010, Spain Recruiting Hernández Suárez, MD
Hospital de Sagunto | Sagunto, 46520, Spain Recruiting Delgado Vicente, MD
Hospital de Sagunto | Valencia, Spain Recruiting Christina Rivaa, MD Principal Investigator
Hospital la Plana | Villarreal, 12540, Spain Recruiting El-Qutob Lopez, MD
Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases | Chernivtsi, 58023, Ukraine Recruiting Koloskova, MD
Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center | Dnipro, 49006, Ukraine Recruiting Naumenko, MD
Dnipro City Children's Municipal Clinical Hospital #2 | Dnipro, Ukraine Recruiting Svitlana Ilchenko, MD Principal Investigator
City Children's Clinic № 16" of Kharkiv City Council | Kharkiv, 61000, Ukraine Recruiting Makeeva, MD
City Children's Clinical Hospital # 19" of Kharkiv City Council | Kharkiv, 61000, Ukraine Recruiting Klymenko, MD
Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine | Kryvyi Rih, 50082, Ukraine Recruiting Lytvynova, MD
O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear | Kyiv, 03057, Ukraine Recruiting Gogunska, MD
State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine | Kyiv, 03680, Ukraine Recruiting Rechkina, MD
Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine | Kyiv, 04050, Ukraine Recruiting Lapshyn, MD
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center | Lviv, 79000, Ukraine Recruiting Besh, MD
Odesa Regional Children's Clinical Hospital" of Odesa Regional Council | Odesa, 65031, Ukraine Recruiting Aryayev, MD
Children's Clinical Hospital of Poltava Regional Council | Poltava, 36011, Ukraine Recruiting Kryuchko, MD
Regional Children Clinical Hospital, Infectious-Diagnostic Department | Sumy, 40031, Ukraine Recruiting Loboda, MD
Regional Children's Clinical Hospital of Vinnytsia Regional Council | Vinnytsya, 21029, Ukraine Recruiting Yablon, MD
City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department | Zaporizhzhya, 69076, Ukraine Recruiting Nedelska, MD
Расположение Страны

Bulgaria

Canada

France

Germany

Lithuania

Poland

Russian Federation

Slovakia

Spain

Ukraine

United States

Дата проверки

2021-11-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Allergic rhinitis
  • ХДМ
  • педиатрический
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Active treatment

Тип: Experimental

Описание: HDM SLIT-tablet plus allergy and asthma rescue medication

Метка: Плацебо

Тип: Плацебо Компаратор

Описание: Пероральная таблетка плацебо плюс лекарство от аллергии и астмы

Акроним MATIC
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное назначение

Первичное назначение: Уход

Маскировка: Дубль (Участник, Исследователь)

Описание маскировки: Двойной слепой