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Идёт набор NCT06392776

Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

Без фазы С лечением COPD 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
В протоколе указаны: Early diagnosis and treatment.
Кому может быть актуально
Состояния в реестре: COPD, Asthma. Базовые параметры: от 18 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
Канада
Следующий шаг
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Обзор

Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life. The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals. The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.

Вмешательства

  • Другое Early diagnosis and treatment
    Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner

Первичные конечные точки

  • Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). [Срок оценки: 12 weeks]
Вторичные конечные точки (6)
  • Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT) [Срок оценки: 12 weeks]
  • Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing. [Срок оценки: 12 weeks]
  • Differences between the experimental group and the control group in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period. [Срок оценки: 12 weeks]
  • Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes [Срок оценки: 12 weeks]
  • Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI) [Срок оценки: 12 weeks]
  • Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Individuals at least 18 years old
  • Individuals must be symptomatic with respiratory symptoms
  • Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
  • Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
  • Individual must be able to perform pre and post bronchodilator spirometry to measure lung function

Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):

  • Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT.

Критерии исключения

  • Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
  • Individuals currently under the care of a Respirologist.
  • Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
  • Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
  • Individuals who are in the third trimester of pregnancy
  • Individuals involved in another interventional trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

Канада · 4 центра
  • St. Joseph's Hamilton Healthcare — Hamilton
  • Ottawa Hospital General Campus — Ottawa
  • Royal University Hospital — Saskatoon
  • Institut universitaire de cardiologie et de pneumologie de Québec — Québec

Идентификаторы

NCT: NCT06392776 · Protocol ID 4373

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗