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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
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; (4)) will guide swallowing assessment and cardiac work-up, respectively. If a sputum sample is not produced as an outpatient spontaneously, then sputum induction will be pursued 8 weeks after discharge. If there are no sputum samples to guide inhaler regimen, then it will be determined by the study physician guided by the Canadian Thoracic Society guidelines (2) if a sputum-guided regimen has not already been established.
As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.
Hamilton General Hospital
Hamilton, Ontario, Canada
NOT_YET_RECRUITINGSt. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITINGSevere exacerbations of COPD
As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.
Time frame: 6 months
Moderate COPD Exacerbation
as defined by worsening of symptoms requiring the use of antibiotics or steroids without ER visit or hospitalization
Time frame: 6 months
Mild COPD Exacerbation
Defined as worsening of symptoms that were self-managed and resolved without systemic steroids or antibiotics; captured by Clinical COPD Questionnaire
Time frame: 6 months
COPD exacerbation associated with inflammation
Defined as an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture
Time frame: 6 months
Time to first COPD exacerbation associated with inflammation
Defined as time to an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture
Time frame: 6 months
Time to first COPD exacerbation
Defined as time to an exacerbation (as defined previously)
Time frame: 6 months
Change in Clinical COPD Questionnaire
Change in Clinical COPD Questionnaire between Week 0 and Week 26.
Time frame: 26 weeks
Change in COPD Assessment Test
Change in COPD Assessment Test between Week 0 and Week 26.
Time frame: 26 weeks
Change in Patient Health Questionnaire-9
Change in Patient Health Questionnaire-9 between Week 0 and Week 26.
Time frame: 26 weeks
Change in General Anxiety Disorder-7 questionnaire
Change in General Anxiety Disorder-7 questionnaire between Week 0 and Week 26.
Time frame: 26 weeks
EQ-5D-5L questionnaire
Change in EQ-5D-5L between Week 0 and Week 26.
Time frame: 26 weeks
FEV1
Change in FEV1 between clinic visits 1 and 3.
Time frame: 16 weeks
Sputum eosinophil percentage
Change in sputum eosinophil percentage between clinic visits 1 and 3
Time frame: 16 weeks
Sputum neutrophil count
Change in sputum neutrophil count between clinic visits 1 and 3
Time frame: 16 weeks
Sputum abnormalities rectified
The number of subjects who have their sputum abnormalities rectified will be recorded between clinics 1 and 3
Time frame: 16 weeks
Use of oral or inhaled corticosteroid
Cumulative dose of oral and inhaled corticosteroid
Time frame: 6 months
Use of antibiotics
Cumulative courses of oral or intravenous antibiotics
Time frame: 6 months
Participant recruitment number
number of patients approached for recruitment during study
Time frame: 2 years
Reason for non-participation
reasons for non-participation during recruitment period
Time frame: 2 years
Clinic attendance
Number of clinic visits attended while enrolled in the study
Time frame: 6 months
Number of days to visit 1
number of days to visit 1 from hospital discharge
Time frame: Should fall within a 2-3 week window
Number of clinic visits
Number of clinic visits patients attend during the 6 months that they are participating in the study
Time frame: 6 months
Patient care
number of nursing telephone calls initiated by the patient, number of adequate sputum samples collected, and the number referred to a smoking cessation program
Time frame: study duration
Side effects
Side effects will be captured by noting peak serum glucose levels and blood pressure measured in-hospital, and the occurrence of psychosis, candidiasis, C. difficile infection, and gastrointestinal upset as reported by the patient during clinic visits
Time frame: 26 weeks
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