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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Combination product 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
• Other Usual Care
  As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.

Primary outcome measures

• Severe exacerbations of COPD [Time frame: 6 months]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

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

Publications

• 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

Identifiers

NCT: NCT04890938 · 13532

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗