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Идёт набор NCT04796844

MANI Real-life Perspective Observatory

Наблюдательное Asthma Mild Asthma Moderate Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Asthma, Mild Asthma, Moderate Asthma. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Mild/Moderate Asthma Network of Italy Observatory

Обзор

The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

Подробное описание

To represent real-world mild moderate Italian asthmatics, all adults with diagnosed asthma by specialist, according GINA (Global Initiative for Asthma) document, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her general practitioners will be delivered.

Subjects follow up will be scheduled according with GINA document and center plan (6 or 12 months follow up visit).

Первичные конечные точки

  • A cluster-based, real world, cross-sectional perspective, observational cohort study [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
Вторичные конечные точки (12)
  • Real life assessment of control, exacerbation and PROs in patients treated with different drugs and schedule [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Asthma control in pregnant women [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Burden of OCS in mild and moderate asthma [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • SABA use in mild and moderate asthma [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Influence of infections and vaccinations on disease outcomes and progression [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Influence of upper airway disease on disease outcomes and progression [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Impact of inhalation techniques and smart inhalers on disease outcomes and progression [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Environmental exposure influences on disease outcome and progression [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Evolution of inflammatory patterns over time [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Role of smoking and life style in lung function and disease progression [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Patients reported outcomes over time [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
  • Patient awareness and engagement in mild and moderate asthma [Срок оценки: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]

Критерии участия

Критерии включения

  • Adult patients
  • Asthma diagnosis according GINA 2020 algorithm (Annex 1)
  • Patients enrolled in other previous or ongoing observational studies

Критерии исключения

  • Severe asthma patients according International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. \[Chung KF et al. European Respiratory Journal Feb 2014, 43 (2) 343-373; DOI: 10.1183/09031936.00202013 (Annex 2)\]
  • Subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS Ospedale Policlinico San Martino — Genova

Публикации

  • Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.0020201 PMID 24337046
  • Braido F, Blasi F, Canonica GW, Paggiaro P, Beghe B, Bonini M, Carpagnano GE, Del Giacco S, Lavorini F, Milanese M, Patella V, Santus P, Contoli M; MANI Network; Allegrini C, Baiardini I, Bonzano L, Caiaffa MF, Castelnuovo P, Corsico AG, Cosmi L, Costantino MT, Cottini M, Crimi N, Crivellaro MA, D'Alo S, Folletti I, Fornari D, Foschino-Barbaro MP, Franceschini L, Gargano D, Oliani KL, Maniscalco M PMID 34469268

Идентификаторы

NCT: NCT04796844 · 456/2020 - DB id 10481 · MANI Project

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗