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.
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
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
Parallel
biomarker-guided decision making
Other intervention-recommendations for antibiotic and steroid Rx provided to study physician based on bio-marker (serum CRP, blood eosinophils, sputum colour) results.
GOLD recommendations
Other interventionRecommendations provided to study physician for Rx of antibiotics and steroids based on current GOLD recommendations
The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period.
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
To determine what proportion of patients had exacerbations after enrollment but prior to randomization, that were missed by the study.
This outcome is needed to evaluate if our method of capturing exacerbations is effective. -The number of times a patient was prescribed antibiotics and/or steroids between enrollment and randomization divided by number of patients enrolled.
To determine what proportion of physicians were adherent to the treatment recommendations provided.
To determine if physicians are willing to consider using this protocol in a study, to approximate the amount of cross-over we might get if the larger trial is not a phase 3 study -The number of prescriptions adherent to biomarker recommendations divided by the number of subjects randomized to the intervention arm
To determine what percentage of patients would fall into each category: What percentage had blood eosinophils > = 2% ? What percentage had CRP > = 40? What percentage had CRP < 20? What percentage had purulent sputum ?
To determine if we would get enough patients in all categories for a larger trial to be feasible. * the number of randomized subjects with blood eosinophils \> =2% divided by the total number of randomized subjects * the number of randomized subjects with CRP \> = 40 divided by total number of randomized subjects * the number of randomized subjects with CRP \< 20 divided by the total number of randomized subjects * the number of randomized subjects with purulent sputum divided by the total number of randomized subjects
To determine what percentage of patients had taken a photograph of their sputum or brought sputum to be assessed in-person.
To determine if we would be able to reliably assess sputum purulence using this methodology in a larger trial -number of randomized subjects with photographs of sputum or sputum brought in container to in-person appointment divided by the total number of randomized subjects
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Ottawa Hospital Research Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
