NCT06929767Not yet recruitingPhase 4
Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?
Biomarker Guided Decision-making in Acute Exacerbation of COPD: a Feasibility Study
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- COPD
- NCT number
- NCT06929767
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 1 Sept 2025 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- acute heart failure day of randomization
- allergy/absolute contraindication to the use of oral steroids
- COVID positive
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.