Blood Tests to Guide Treatment During Flares of COPD
Tests whether two simple blood tests can guide steroid and antibiotic use in COPD flares.
Plain-language title generated from the registry record
Registry title: Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?
Key facts
- Where
- Ottawa, CanadaSee the site
- Phase
- Phase 4
Where in Canada
- The Ottawa HospitalOttawa, CanadaNo longer taking part
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?
Trial details
- Who runs it
- Ottawa Hospital Research Institute
- Trial code
- NCT06929767
- Record updated
- 16 April 2025
- Original description
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:Read full original descriptionShow less
Biomarker Guided Decision-making in Acute Exacerbation of COPD: a Feasibility Study
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.
Inclusion: 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: acute heart failure day of randomization; allergy/absolute contraindication to the use of oral steroids; COVID positive; 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; known immunosuppression including the use of chronic glucocorticoids day of randomization; planned pregnancy or currently pregnant.