Tests sputum-guided medicines and care support for people with COPD
Tests sputum-guided treatment and care support in adults with COPD, a lung disease.
Key facts
- Who runs it
- McMaster University
- Where
- Hamilton, CanadaSee the 2 sites
- Trial code
- Registry title
- Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial
- Status
- Recruiting
- People taking part
- 128 people, planned
- Started
- 27 May 2022
- Planned end
- Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sputum-guided management and comprehensive care management
- Usual Care
- Record updated
- 21 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with COPD who have had at least 2 flare-ups in the last 12 months and a smoking history.
- Age
- 40 years and older
- Sex
- All sexes can join.
- Disease stage
- COPD with at least 2 flare-ups (exacerbations) in the last 12 months, and either FEV1/FVC below 0.7 or emphysema seen on scans.
- Biomarker or test result
- FEV1/FVC below 0.7 (a lung function test) or emphysema seen on imaging.
Main reasons for not taking part
- Severe mental illness not controlled by medication
- Life expectancy of less than 6 months
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- >=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 take part
- severe mental illness not controlled by medication or life-expectancy less than 6-months
Where in Canada
- Hamilton General HospitalHamilton, CanadaContact: Terence Ho, MB MScNot yet recruiting
- St. Joseph's Healthcare HamiltonHamilton, CanadaContact: Terence Ho, MB MScTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Sputum-guided management and comprehensive care managementTreatment being tested
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.
- Usual CareExisting treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
- Plain-language title
- Tests sputum-guided medicines and care support for people with COPDGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 November 2024