Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial

Официальное название

Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial

Обзор

Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem. Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical care. The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right medicines will have fewer COPD flare-ups than those who get normal care.

Подробное описание

STRIVE is a randomized-controlled trial comparing a two-pronged intervention, including sputum-biomarker-directed treatment of airway inflammation, and comprehensive care management, to usual care, for COPD patients with frequent exacerbation from two sites.

The intervention consists of 6-months of comprehensive care management (CCM) and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits will occur at 2, 6 and 16 weeks after hospital discharge. For the intervention group, the key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Spontaneous sputum biomarkers will be used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge.

Вмешательства

• Комбинированный продукт Sputum-guided management and comprehensive care management
  Those in the intervention group will have their treatment determined by the presence and type of airway inflammation whether during AECOPD or as part of clinic optimization. Corticosteroids are given for airway eosinophilia (sputum eosinophils \>3%), and antibiotics for airway neutrophilia (sputum neutrophils ≥65% and total cells \>10 million cells/gram) or a positive sputum culture. Specialized stains to identify aspiration (Oil Red O; (3)) and left ventricular dysfunction (Perl's Prussian blue
• Другое Usual Care
  As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.

Первичные конечные точки

• Severe exacerbations of COPD [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Moderate COPD Exacerbation [Срок оценки: 6 months]
• Mild COPD Exacerbation [Срок оценки: 6 months]
• COPD exacerbation associated with inflammation [Срок оценки: 6 months]
• Time to first COPD exacerbation associated with inflammation [Срок оценки: 6 months]
• Time to first COPD exacerbation [Срок оценки: 6 months]
• Change in Clinical COPD Questionnaire [Срок оценки: 26 weeks]
• Change in COPD Assessment Test [Срок оценки: 26 weeks]
• Change in Patient Health Questionnaire-9 [Срок оценки: 26 weeks]
• Change in General Anxiety Disorder-7 questionnaire [Срок оценки: 26 weeks]
• EQ-5D-5L questionnaire [Срок оценки: 26 weeks]
• FEV1 [Срок оценки: 16 weeks]
• Sputum eosinophil percentage [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• >=2 exacerbations of COPD in the last 12-months, FEV1/FVC<0.7 or radiologic emphysema, with a >-10 pack-year smoking history

Критерии исключения

• severe mental illness not controlled by medication or life-expectancy less than 6-months

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

Лечение

Центры проведения

Канада · 2 центра

• Hamilton General Hospital — Hamilton
• St. Joseph's Healthcare Hamilton — Hamilton

Публикации

• Nici L, ZuWallack R. Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. COPD. 2018 Jun;15(3):223-230. doi: 10.1080/15412555.2018.1501671. Epub 2018 Sep 5. PMID 30183417
• Bourbeau J, Bhutani M, Hernandez P, Marciniuk DD, Aaron SD, Balter M, et al. CTS position statement: Pharmacotherapy in patients with COPD-An update. Canadian Journal of Respiratory, Critical Care, and Sleep Medicine. 2017;1(4):222-41.
• Wilson AM, Nair P, Hargreave FE, Efthimiadis AE, Anvari M, Allen CJ; ELVIS Research Study Group. Lipid and smoker's inclusions in sputum macrophages in patients with airway diseases. Respir Med. 2011 Nov;105(11):1691-5. doi: 10.1016/j.rmed.2011.07.011. Epub 2011 Aug 9. PMID 21831624
• Leigh R, Sharon RF, Efthimiadis A, Hargreave FE, Kitching AD. Diagnosis of left-ventricular dysfunction from induced sputum examination. Lancet. 1999 Sep 4;354(9181):833-4. doi: 10.1016/S0140-6736(99)80018-X. PMID 10485730

Идентификаторы

NCT: NCT04890938 · 13532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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