Blood Tests for COPD Flare-Ups

(Bidex Trial)

Overseen By Vanessa PJ Luks, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Chronic glucocorticoids

Disqualifiers: Asthma, Severe bronchiectasis, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves assessing medication use during COPD flare-ups, it's possible that you may need to adjust your medications as directed by the study doctor.

What data supports the effectiveness of the treatment Blood Tests (C reactive protein and eosinophils) for COPD flare-ups?

Research shows that testing for C-reactive protein (CRP) can help guide antibiotic use during COPD flare-ups, potentially reducing unnecessary antibiotic prescriptions. Additionally, higher CRP levels are linked to worse outcomes in COPD, suggesting that monitoring CRP could be useful in managing the condition. ^{1 2 3 4 5}

Is it safe to use blood tests for C-reactive protein and eosinophils in humans?

Research shows that using C-reactive protein tests to guide antibiotic use in COPD flare-ups is safe and does not harm patients. Additionally, higher blood eosinophil counts are linked to shorter hospital stays and lower mortality in COPD exacerbations, suggesting these tests are safe for use in humans. ^{1 2 6 7 8}

How does the blood test treatment for COPD flare-ups differ from other treatments?

This treatment uses blood tests to measure C-reactive protein (CRP) and eosinophils, which can help guide the use of antibiotics and predict outcomes in COPD flare-ups. Unlike traditional treatments that focus on medication, this approach uses biomarkers to tailor treatment, potentially reducing unnecessary antibiotic use and improving patient outcomes. ^{1 2 6 9 10}

Research Team

Vanessa PJ Luks, MD

Principal Investigator

OHRI

Eligibility Criteria

This trial is for outpatients with a confirmed diagnosis of COPD who are experiencing an increase in respiratory symptoms. They must have documented COPD by spirometry or specialist's diagnosis, and be willing to consent. Excluded are those with new lung infiltrates, high fever, positive blood culture on the day of randomization, co-morbid asthma or severe bronchiectasis, acute heart failure, known immunosuppression including chronic steroid use, allergy to oral steroids, or current/planned pregnancy.

Inclusion Criteria

Consent provided

I have COPD confirmed by a lung function test or a specialist.

My COPD symptoms have worsened, requiring more medication.

Exclusion Criteria

New infiltrate on chest x-ray day of randomization

Temperature ≥ 38.0 ◦C taken orally day of randomization

Planned pregnancy or currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biomarker-guided or standard care treatment for AECOPD

4 weeks

1 in-person visit for randomization and treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 follow-up calls at days 3, 14, and 30

Treatment Details

Interventions

• Blood Tests (C reactive protein and eosinophils)

Trial Overview The study tests if using two blood tests (C reactive protein and eosinophils) can guide decisions to reduce unnecessary antibiotics and steroids during COPD flare-ups without compromising treatment success. It's a feasibility study assessing participant recruitment over 12 months, medication adherence, protocol compliance, data completeness at study end and willingness to provide phlegm samples.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

If randomized to the intervention arm (biomarker-guided therapy), the physician will be provided with the biomarker-guided recommendations and will access Epic to look at the patient's biomarkers. The physician will then write a Rx for the patient keeping these recommendations in mind (but not being bound by them). Patient allergies will be taken into account when writing the Rx. * if blood eosinophils are \>=2%, steroids are recommended * if blood eosinophils are \< 2%, steroids are not recommended (unless the patient also has CRP \< 20 with non-purulent sputum, then an abbreviated course of steroids can be considered) * if CRP is \>= 40 mg/L,or \>=20 with purulent sputum, antibiotics are recommended; if neither condition is met, antibiotics are not recommended.

Group II: Standard of care arm Active Control 1 Intervention

If randomized to the control arm (standard of care) arm, the physician will write a prescription based on what they feel is standard of care (and will not look at the biomarker results). Patient allergies will be taken into account when writing the Rx. * standard of care recommendations based on most recent GOLD publication will be provided which currently include: * steroids in all patients with AECOPD * antibiotics only if there are 2 out of 3 cardinal symptoms (dyspnea, cough, sputum), and one of the symptoms has to be purulent sputum

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Can a point-of-care CRP test reduce antibiotic use in COPD? [2021]

2. England pubmed.ncbi.nlm.nih.gov

C reactive protein testing in general practice safely reduces antibiotic use for flare-ups of COPD. [2020]

3. Greece pubmed.ncbi.nlm.nih.gov

C-reactive protein as a prognostic marker in chronic obstructive pulmonary disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Eosinophils in COPD Exacerbations Are Associated With Increased Readmissions. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as inflammation markers in elderly patients with stable chronic obstructive pulmonary disease (COPD). [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The acute wheezy adult with airways disease in the emergency department: a retrospective case-note review of exacerbations of COPD. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Can we use a biomarker to guide antibiotic treatment in severe COPD exacerbations? [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Proteoglycan 4 is a diagnostic biomarker for COPD. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

C-reactive protein levels in patients with chronic obstructive pulmonary disease: role of infection. [2015]