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

Condition(s) studied

Investigational drug(s) / intervention(s)

biomarker-guided decision making: -recommendations for antibiotic and steroid Rx provided to study physician based on bio-marker (serum CRP, blood eosinophils, sputum colour) results.

GOLD recommendations: Recommendations provided to study physician for Rx of antibiotics and steroids based on current GOLD recommendations

Study summary

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.

Eligibility

Primary outcome measure(s)

• The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period. — 12 months
  We need to know if this is a study that patients would want to do, and if this is a study that physicians would be willing to enroll or refer patients to. * number screened: an absolute count of patients who are contacted by the RA for initial screening and information * proportion enrolled: number of subjects who verbally consent divided by number of subjects screened * proportion randomized: number of subjects who had an exacerbation and were randomized divided by number of subjects enrolled

Trial sites (1)

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