Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• The Ottawa Hospital, Ottawa, Ontario, Canada

Who to contact

Vanessa PJ Luks, MD · 613-737-8198 · vluks@toh.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06929767.