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Идёт набор NCT06376994

Multi-Center Clean Air Randomized Controlled Trial in COPD

Фаза III С лечением Chronic Obstructive Pulmonary Disease (COPD)

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: Air cleaner, Sham air cleaner.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 40 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

Подробное описание

The Multi-Center Clean Air Randomized Controlled Trial in COPD (Clean Air) is a multi-center, prospective, randomized, double-blind, sham-controlled trial that will enroll 770 former smokers with COPD over a 4-year period and follow participants at regular intervals for one year. The primary endpoint is respiratory specific quality of life. Secondary endpoints include rate of acute exacerbations, rescue medication use, quality of life, and cost-effectiveness.

Вмешательства

  • Устройство Air cleaner
    The intervention is two active air cleaners with high efficiency particulate air (HEPA) filters which remove PM, as well as activated carbon filters to remove NO2 (and other trace gases). These will be run for a year in a participant's house.
  • Устройство Sham air cleaner
    The sham intervention is two sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow, and overall appearance compared to active air cleaners, thus blinding participants to filter status. These will be run for a year in a participant's house.

Первичные конечные точки

  • St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: baseline and 3, 6, 9, and 12 months after baseline]

Критерии участия

Критерии включения

To be eligible, subjects must meet all these criteria:

  • Age ≥ 40 years.
  • Self-report of physician diagnosis of COPD.
  • Spirometry confirmed airway obstruction (post-bronchodilator spirometry of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.7) as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (6, 11)
  • Tobacco exposure ≥ 10 pack-years. This refers to regular cigarette tobacco consumption.
  • Self-reported former smoker of at least 6 months' duration. This does not include e-cigarette use.
  • COPD Assessment Test (CAT) score ≥ 10, Modified Medical Research Council dyspnea scale (mMRC) ≥ 2, or history of moderate or severe exacerbation in the past 12 months (as defined by history of receiving a course of systemic corticosteroids or antibiotics for respiratory problems; or visiting an emergency department or being hospitalized for a COPD exacerbation within the past 12 months.)

Критерии исключения

To be eligible, subjects must not meet any one of these criteria:

  • Living in a location other than home (e.g., long-term care facility, nursing home)
  • Other chronic lung diseases, except asthma
  • Condition with less than a year of life expectancy (e.g., metastatic cancer) or in hospice
  • Spends >2 months per year in location other than home; or plans to change residence in the next 12 months
  • Pregnant or breastfeeding
  • Current air cleaner use in the home (\*If the individual is willing to discontinue use of the personal air cleaner, this person can be eligible if all other eligibility has been met)
  • Inability to bring air cleaners (about 15 pounds each) into home, either by self, friend, or relative
  • Deemed by the study investigator to be unable to complete study protocol, including likely lack of internet connectivity
  • Participating in another interventional clinical 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
Четверное слепое
Основная цель
Профилактика

Центры проведения

США · 11 центров
  • University of Alabama, Lung Health Center — Birmingham
  • University of California, Los Angeles — Los Angeles
  • University of Iowa — Iowa City
  • University of Maryland — Baltimore
  • Johns Hopkins — Baltimore
  • Tidal Health — Salisbury
  • Beth Israel Deaconess Medical Center — Boston
  • University of Michigan — Ann Arbor
  • … и ещё 3 центра

Идентификаторы

NCT: NCT06376994 · IRB00407311 · 1U24HL169566-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗