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Идёт набор NCT07505602

Air Purifier Use and Respiratory Health in COPD Patients

Без фазы С лечением Respiratory Health

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: Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters, Using air purifiers with non-functional filtration system.
Кому может быть актуально
Состояния в реестре: Respiratory Health. Базовые параметры: 50 лет — 80 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
Китай
Следующий шаг
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Официальное название

Respiratory Benefits of Indoor Air Purification in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Обзор

This randomized, double-blind, parallel-controlled trial aims to evaluate the effects of an indoor air purifier intervention on respiratory health in patients with Chronic Obstructive Pulmonary Disease (COPD).

Подробное описание

This randomized, double-blind, parallel-controlled trial will evaluate the effects of a 12-month home-based air purification intervention on respiratory health in non-smoking COPD patients in China. Participants will be randomized to receive an active or sham air purifier, with all participants and outcome assessors blinded to allocation. Health assessments, including clinical evaluation (e.g., pulmonary function tests, impulse oscillometry, and high-resolution computed tomography of the chest, etc.), questionnaire surveys (e.g., St. George's Respiratory Questionnaire and COPD Assessment Test, etc.), and biological sample collection (e.g., venous blood and urine, etc.), will be conducted at baseline and during follow-up visits at the 1st, 3rd, 6th, and 12th months. In addition, monthly telephone follow-ups will be performed to assess respiratory health status throughout the study.

Вмешательства

  • Поведенческое Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters
    Participants in the intervention arm will receive active air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.
  • Поведенческое Using air purifiers with non-functional filtration system
    Participants in the intervention arm will receive sham air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.

Первичные конечные точки

  • Changes in the percentage of low attenuation area at -950 Hounsfield units (%LAA-950) [Срок оценки: Baseline and after the completion of the intervention period (12 months anticipated)]
  • Changes of wall area percentage (WA%) [Срок оценки: Baseline and after the completion of the intervention period (12 months anticipated)]
  • Changes of forced expiratory volume in 1 s (FEV1) [Срок оценки: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)]
Вторичные конечные точки (3)
  • Changes of St. George's Respiratory Questionnaire (SGRQ) score [Срок оценки: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)]
  • Changes of COPD Assessment Test (CAT) score [Срок оценки: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)]
  • COPD exacerbations [Срок оценки: Baseline and monthly thereafter through the 12th month]

Критерии участия

Критерии включения

  • Age between 50 and 80 years old
  • Physician diagnosis of COPD
  • Living in Shanghai during the intervention period
  • Subjects who have no plans to change homes during the intervention period
  • Non-smokers and former smokers

Критерии исключения

  • Subjects living in a location other than home
  • Subjects with a history of alcohol abuse
  • Subjects with other chronic lung diseases, such as active tuberculosis, pulmonary fibrosis, cystic fibrosis, or alpha-1 antitrypsin deficiency
  • Subjects with a history of thoracic surgery
  • Subjects with a history of malignant tumors, such as lung cancer, liver cancer, or gastric cancer
  • Subjects with diagnosed chronic hepatic or renal insufficiency, such as liver cirrhosis, chronic viral hepatitis, or autoimmune liver disease
  • Subjects with acute myocardial infarction or unstable arrhythmia diagnosed within the past 6 weeks
  • Subjects currently participating in other interventional studies

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • School of Public Health, Fudan University — Шанхай

Идентификаторы

NCT: NCT07505602 · FDUEH-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗