Blood Tests to Guide Treatment During Flares of COPD

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for outpatients with known COPD who have a flare. It tests whether two blood tests can guide use of antibiotics and steroids.

Sex

Men and women can join.

Disease stage

A known COPD diagnosis, confirmed by earlier breathing tests or by a lung specialist. The person must have a flare, meaning more breathing symptoms that need more medication.

Main reasons for not taking part

• New infiltrate on chest x-ray on the day of randomization
• Temperature of 38.0 ◦C or higher on the day of randomization
• Positive blood culture on the day of randomization
• Asthma or severe bronchiectasis together with COPD
• Acute heart failure, known immunosuppression or long-term steroid use, allergy to oral steroids, pregnancy, or COVID positive

The registry criteria, word for word

What the trial wants to find out

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:

The 2 groups in the trial

• Intervention ArmOther group

  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.

  Treatment: biomarker-guided decision making

• Standard of care armExisting treatment, for comparison

  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

  Treatment: GOLD recommendations