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

COPD Clinical Trial

— STRIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890938
• Other study ID #: 13532
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: October 27, 2024

Study information

• Verified date: November 2023
• Source: McMaster University
• Contact: Terence N Ho, MB, MSc
• Phone: 9055221155
• Email: hot4[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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; (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.

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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Hamilton Academic Health Sciences Organization, Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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.

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe exacerbations of COPD	As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.	6 months
Secondary	Moderate COPD Exacerbation	as defined by worsening of symptoms requiring the use of antibiotics or steroids without ER visit or hospitalization	6 months
Secondary	Mild COPD Exacerbation	Defined as worsening of symptoms that were self-managed and resolved without systemic steroids or antibiotics; captured by Clinical COPD Questionnaire	6 months
Secondary	COPD exacerbation associated with inflammation	Defined as an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture	6 months
Secondary	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	6 months
Secondary	Time to first COPD exacerbation	Defined as time to an exacerbation (as defined previously)	6 months
Secondary	Change in Clinical COPD Questionnaire	Change in Clinical COPD Questionnaire between Week 0 and Week 26.	26 weeks
Secondary	Change in COPD Assessment Test	Change in COPD Assessment Test between Week 0 and Week 26.	26 weeks
Secondary	Change in Patient Health Questionnaire-9	Change in Patient Health Questionnaire-9 between Week 0 and Week 26.	26 weeks
Secondary	Change in General Anxiety Disorder-7 questionnaire	Change in General Anxiety Disorder-7 questionnaire between Week 0 and Week 26.	26 weeks
Secondary	EQ-5D-5L questionnaire	Change in EQ-5D-5L between Week 0 and Week 26.	26 weeks
Secondary	FEV1	Change in FEV1 between clinic visits 1 and 3.	16 weeks
Secondary	Sputum eosinophil percentage	Change in sputum eosinophil percentage between clinic visits 1 and 3	16 weeks
Secondary	Sputum neutrophil count	Change in sputum neutrophil count between clinic visits 1 and 3	16 weeks
Secondary	Sputum abnormalities rectified	The number of subjects who have their sputum abnormalities rectified will be recorded between clinics 1 and 3	16 weeks
Secondary	Use of oral or inhaled corticosteroid	Cumulative dose of oral and inhaled corticosteroid	6 months
Secondary	Use of antibiotics	Cumulative courses of oral or intravenous antibiotics	6 months
Secondary	Participant recruitment number	number of patients approached for recruitment during study	2 years
Secondary	Reason for non-participation	reasons for non-participation during recruitment period	2 years
Secondary	Clinic attendance	Number of clinic visits attended while enrolled in the study	6 months
Secondary	Number of days to visit 1	number of days to visit 1 from hospital discharge	Should fall within a 2-3 week window
Secondary	Number of clinic visits	Number of clinic visits patients attend during the 6 months that they are participating in the study	6 months
Secondary	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	study duration
Secondary	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	26 weeks