COPDSTRIVENCT04890938
Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial
A study testing Sputum-guided management and comprehensive care management in people with COPD, run by McMaster University at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Sputum-guided management and comprehensive care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- 27 May 2022to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=2 exacerbations of COPD in the last 12-months, FEV1/FVC<0.7 or radiologic emphysema, with a >-10 pack-year smoking history
Who cannot join
- severe mental illness not controlled by medication or life-expectancy less than 6-months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Terence Ho, MB MSc, 905-522-1155 ext. 32995, hot4@mcmaster.ca
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Terence Ho, MB MSc, 9055221155 ext. 32995, hot4@mcmaster.ca
Terence Ho, MB MSc
About this study
Official title: Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Sputum-guided management and comprehensive care management, Usual Care
- Keywords
- COPD, Exacerbation, Comprehensive care management, Sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum-guided management and comprehensive care managementCombination product
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.
Usual CareOther
As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.
| Study group | Role | What they receive |
|---|---|---|
| Sputum-guided management and comprehensive care management | Experimental | The intervention consists of 6-months of CCM and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits at 2, 6, and 16 weeks. The key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Clinic nurse will review inhaler technique with the patient. Sputum (spontaneous) biomarkers will be measured with results used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge, at both sites. Receives: Combination Product: Sputum-guided management and comprehensive care management |
| Usual Care | Active comparator | This group will also receive clinic visits at 2, 6, and 16 weeks with a study physician, and also education material, inhaler technique assessment and education, and case management from the clinic personnel. The study physician will pursue further investigation and/or further intervention if they see fit. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (23)
Moderate COPD Exacerbation
as defined by worsening of symptoms requiring the use of antibiotics or steroids without ER visit or hospitalization
Measured: 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
Measured: 6 months
COPD exacerbation associated with inflammation
Defined as an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture
Measured: 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
Measured: 6 months
Time to first COPD exacerbation
Defined as time to an exacerbation (as defined previously)
Measured: 6 months
Change in Clinical COPD Questionnaire
Change in Clinical COPD Questionnaire between Week 0 and Week 26.
Measured: 26 weeks
Change in COPD Assessment Test
Change in COPD Assessment Test between Week 0 and Week 26.
Measured: 26 weeks
Change in Patient Health Questionnaire-9
Change in Patient Health Questionnaire-9 between Week 0 and Week 26.
Measured: 26 weeks
Change in General Anxiety Disorder-7 questionnaire
Change in General Anxiety Disorder-7 questionnaire between Week 0 and Week 26.
Measured: 26 weeks
EQ-5D-5L questionnaire
Change in EQ-5D-5L between Week 0 and Week 26.
Measured: 26 weeks
FEV1
Change in FEV1 between clinic visits 1 and 3.
Measured: 16 weeks
Sputum eosinophil percentage
Change in sputum eosinophil percentage between clinic visits 1 and 3
Measured: 16 weeks
Sputum neutrophil count
Change in sputum neutrophil count between clinic visits 1 and 3
Measured: 16 weeks
Sputum abnormalities rectified
The number of subjects who have their sputum abnormalities rectified will be recorded between clinics 1 and 3
Measured: 16 weeks
Use of oral or inhaled corticosteroid
Cumulative dose of oral and inhaled corticosteroid
Measured: 6 months
Use of antibiotics
Cumulative courses of oral or intravenous antibiotics
Measured: 6 months
Participant recruitment number
number of patients approached for recruitment during study
Measured: 2 years
Reason for non-participation
reasons for non-participation during recruitment period
Measured: 2 years
Clinic attendance
Number of clinic visits attended while enrolled in the study
Measured: 6 months
Number of days to visit 1
number of days to visit 1 from hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start27 May 2022
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Terence Ho, MB, MSc, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890938
- Sponsor's protocol ID
- 13532
- Acronym
- STRIVE
- Status last verified
- Nov 2024
- First submitted
- 13 May 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30183417Bourbeau 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.
PubMed 21831624Leigh 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.
PubMed 10485730
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04890938
- Acronym / sponsor ID
- STRIVE / 13532
- Conditions
- COPD
- Keywords
- COPD, Exacerbation, Comprehensive care management, Sputum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation
- Study start
- 27 May 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sputum-guided management and comprehensive care management | Experimental | Combination Product: Sputum-guided management and comprehensive care managementThe intervention consists of 6-months of CCM and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits at 2, 6, and 16 weeks. The key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Clinic nurse will review inhaler technique with the patient. Sputum (spontaneous) biomarkers will be measured with results used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge, at both sites. |
| Usual Care | Active comparator | Other: Usual CareThis group will also receive clinic visits at 2, 6, and 16 weeks with a study physician, and also education material, inhaler technique assessment and education, and case management from the clinic personnel. The study physician will pursue further investigation and/or further intervention if they see fit. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >=2 exacerbations of COPD in the last 12-months, FEV1/FVC<0.7 or radiologic emphysema, with a >-10 pack-year smoking history
Key exclusion criteria (1 listed)
- severe mental illness not controlled by medication or life-expectancy less than 6-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum-guided management and comprehensive care managementThose 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. | Combination product | Sputum-guided management and comprehensive care management |
| Usual CareAs per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions. | Other | Usual Care |
Primary outcome
Severe exacerbations of COPD
Time frame: 6 months
As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.
23 secondary outcomes
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
Sputum neutrophil count
Time frame: 16 weeks
Sputum abnormalities rectified
Time frame: 16 weeks
Use of oral or inhaled corticosteroid
Time frame: 6 months
Use of antibiotics
Time frame: 6 months
Participant recruitment number
Time frame: 2 years
Reason for non-participation
Time frame: 2 years
Clinic attendance
Time frame: 6 months
Number of days to visit 1
Time frame: Should fall within a 2-3 week window
Number of clinic visits
Time frame: 6 months
Patient care
Time frame: study duration
Side effects
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 30183417Nici 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.
- BackgroundBourbeau 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.
- Background: PubMed 21831624Wilson 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.
- Background: PubMed 10485730Leigh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terence Ho, MB, MSc principal investigator
St. Joseph's Healthcare Hamilton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum-guided management and comprehensive care management in people with COPD, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terence N Ho, MB, MSc (9055221155 ext. 32995, hot4@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe exacerbations of COPD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890938, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.