[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":24,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"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.\n\n* if blood eosinophils are \\>=2%, steroids are recommended\n* if blood eosinophils are \\\u003C 2%, steroids are not recommended (unless the patient also has CRP \\\u003C 20 with non-purulent sputum, then an abbreviated course of steroids can be considered)\n* if CRP is \\>= 40 mg\u002FL,or \\>=20 with purulent sputum, antibiotics are recommended; if neither condition is met, antibiotics are not recommended.",[12],"Other: biomarker-guided decision making",{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of care arm","ACTIVE_COMPARATOR","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.\n\n* standard of care recommendations based on most recent GOLD publication will be provided which currently include:\n* steroids in all patients with AECOPD\n* antibiotics only if there are 2 out of 3 cardinal symptoms (dyspnea, cough, sputum), and one of the symptoms has to be purulent sputum",[18],"Other: GOLD recommendations",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"GOLD recommendations","Recommendations provided to study physician for Rx of antibiotics and steroids based on current GOLD recommendations",[14],[30],{"name":31,"affiliation":32,"role":33},"Vanessa PJ Luks, MD","OHRI","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","613-737-8198","vluks@toh.ca",[40],{"facility":41,"status":24,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Ottawa Hospital","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-75.69812,45.41117,{"lat":51,"lon":50},[54],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":38},{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[58],{"name":59,"class":60},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100587544","phase-4-do-blood-tests-help-to-decide-which-patients-with-flares-of-chronic-obstructive-pulmonary-disease-copd-need-antibiotics-and-steroids-100587544",false,"NCT06929767","Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?","Biomarker Guided Decision-making in Acute Exacerbation of COPD: a Feasibility Study","Bidex","Inclusion Criteria:\n\n* Outpatients with a known diagnosis of COPD (must have prior spirometry documenting FEV1\u002FFVC post-bronchodilator \\\u003C 0.7 or documented respirologist-diagnosis of COPD)\n* Presenting with AECOPD, defined as an increase in respiratory symptoms necessitating an increase in medications\n* Consent provided\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n* new infiltrate on chest x-ray day of randomization\n* temperature ≥ 38.0 ◦C taken orally day of randomization\n* positive blood culture day of randomization\n* co-morbid asthma or severe bronchiectasis\n* acute heart failure day of randomization\n* known immunosuppression including the use of chronic glucocorticoids day of randomization\n* allergy\u002Fabsolute contraindication to the use of oral steroids\n* planned pregnancy or currently pregnant\n* COVID positive","ALL",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","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:\n\nHow many participants will we able to include in the study over 12 months?\n\nHow many participants in the trial will take all of their medications?\n\nWill study protocols be followed?\n\nHow much information will we be missing at the end of the study?\n\nHow 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?\n\nParticipants will:\n\nCome 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.\n\nThe 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.",[78,79,80,81,82],"Chronic Obstructive Pulmonary Disease","COPD","Exacerbation of COPD","AECOPD","ECOPD",[84,85,86,87,88,89,81,90],"bio-maker","C reactive protein","CRP","eosinophils","exacerbation","COPD exacerbation","biomarker","NOT_YET_RECRUITING","2025-04-08",{"date":94,"type":95},"2025-04-16","ACTUAL",{"date":97,"type":72},"2025-09-01",{"date":99,"type":72},"2026-10-01",{"name":5,"class":6},1]