Sputum-guided treatment and care management for COPD
Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
This study tests a new approach for people with COPD that uses sputum tests to guide treatment and offers personalized care to help reduce flare-ups and hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT04890938 on ClinicalTrials.gov |
What this trial studies
This trial investigates a two-pronged intervention for patients with chronic obstructive pulmonary disease (COPD) who experience frequent flare-ups. It combines sputum biomarker-directed treatment of airway inflammation with comprehensive care management over a six-month period. Participants will receive personalized care that includes case management, self-management education, and coordination of resources, alongside regular clinic visits to monitor their condition. The aim is to reduce hospital readmissions and improve overall management of COPD.
Who should consider this trial
Good fit: Ideal candidates are COPD patients with at least two exacerbations in the past year and a history of smoking.
Not a fit: Patients with severe mental illness not controlled by medication or a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of COPD flare-ups and hospital readmissions for patients.
How similar studies have performed: Other studies have shown promise with similar comprehensive care management approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario and 1 other locations
- Hamilton General Hospital — Hamilton, Ontario, Canada (Not_yet_recruiting)
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Terence Ho, MB, MSc — St. Joseph's Healthcare Hamilton
- Study coordinator: Terence N Ho, MB, MSc
- Email: hot4@mcmaster.ca
- Phone: 9055221155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.