Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease… (NCT06929767) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?
Canada80 participantsStarted 2025-09-01
Plain-language summary
The goal of this clinical trial is to see if the use of two simple blood tests: C reactive protein and eosinophils, can reduce the use of steroids and antibiotics in patients with flares of chronic obstructive pulmonary disease (COPD) without reducing the chance of treatment success. Before we undertake a large trial to answer these questions, we need to do a small feasibility study to see if our study design will work. The questions we need to answer include:
How many participants will we able to include in the study over 12 months?
How many participants in the trial will take all of their medications?
Will study protocols be followed?
How much information will we be missing at the end of the study?
How many study participants will take photographs of the phlegm they are coughing up or bring in a sample of the phlegm for inspection by study doctor?
Participants will:
Come into the clinic to be assessed when they have a flare of COPD, get a chest x-ray, blood work, and a doctor visit. The doctor will provide a prescription if it is a flare of COPD.
The participant will get a call 3, 14, and 30 days later by a study researcher to ask questions about if the medications have been taken, if cough or shortness of breath remain, and if they have had to seek additional care from another doctor, clinic, or emergency room.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Outpatients with a known diagnosis of COPD (must have prior spirometry documenting FEV1/FVC post-bronchodilator \< 0.7 or documented respirologist-diagnosis of COPD)
* Presenting with AECOPD, defined as an increase in respiratory symptoms necessitating an increase in medications
* Consent provided
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* new infiltrate on chest x-ray day of randomization
* temperature ≥ 38.0 ◦C taken orally day of randomization
* positive blood culture day of randomization
* co-morbid asthma or severe bronchiectasis
* acute heart failure day of randomization
* known immunosuppression including the use of chronic glucocorticoids day of randomization
* allergy/absolute contraindication to the use of oral steroids
* planned pregnancy or currently pregnant
* COVID positive
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period.