Biomarker Guided Decision-making in Acute Exacerbation of COPD: a Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period.
研究概览
简要总结
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.
详细描述
Study design: randomized, controlled, feasibility trial
Population: Adult patients with a physician diagnosis of COPD suffering from an acute exacerbation of COPD
Intervention: Recommendations for antibiotics and/or glucocorticoids based on CRP, peripheral blood eosinophils +/- sputum colour provided to treating physician.
Comparator: Recommendations for antibiotics and/or glucocorticoids based on current standard of care recommendations in the GOLD guidelines provided to treating physician.
Recruitment/Setting: Patients with COPD will be approached in the outpatient respiratory clinic at The Ottawa Hospital during a visit to see their treating respirologist. The nurse will identify COPD patients to the treating respirologist at the beginning of the visit using coloured flags in Epic. The respirologist will ask the patient if they would like to participate in this study. If they are interested, the patient will be referred to the clinical research assistant. Alternatively, the patient can self-refer by emailing or phoning the research number on the poster. The research assistant will follow-up with the patient via telephone to discuss preferred methods of communication to discuss the trial, updates, and do the informed consent. If applicable, the research assistant will have the patient fill out a consent to communicate via email form. If the research assistant cannot reach the patient via telephone, and they initially received an email, the research assistant may respond to the email with the request that the patient sign the consent to communicate via email before any additional information is provided to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding: The assessing physician is not blinded to group allocation, but if randomized to standard of care, the physician does not access the biomarkers (or in other words the physician writes the Rx blinded to the CRP and blood eosinophil values). The patient is blinded to group allocation and their own biomarker values but not to the specific treatment. In order to ensure the patient cannot see their own bio-markers, these results will not be released to be shared with patients in the electronic medical record. The research assistant (also the outcome assessor) will be blinded to group allocation, and biomarker values, but not to specific treatment.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •acute heart failure day of randomization
- •known immunosuppression including the use of chronic glucocorticoids day of randomization
- •allergy/absolute contraindication to the use of oral steroids
- •planned pregnancy or currently pregnant
- •COVID positive
研究组 & 干预措施
Intervention Arm
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.
干预措施: biomarker-guided decision making (Other)
Standard of care arm
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
干预措施: GOLD recommendations (Other)
结局指标
主要结局
The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period.
时间窗: 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
次要结局
- To determine what proportion of patients had exacerbations after enrollment but prior to randomization, that were missed by the study.(12 months)
- To determine how many patients had complete data collection.(12 months)
- To determine what proportion of physicians were adherent to the treatment recommendations provided.(12 months)
- To determine what percentage of patients had taken a photograph of their sputum or brought sputum to be assessed in-person.(12 months)
- 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 ?(12 months)