Clinical trial
Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
Name
13532
Description
Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem.
Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical care.
The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right medicines will have fewer COPD flare-ups than those who get normal care.
Trial arms
Trial start
2022-05-27
Estimated PCD
2024-09-27
Trial end
2024-10-27
Status
Recruiting
Treatment
Sputum-guided management and comprehensive care management
Those in the intervention group will have their treatment determined by the presence and type of airway inflammation whether during AECOPD or as part of clinic optimization. Corticosteroids are given for airway eosinophilia (sputum eosinophils \>3%), and antibiotics for airway neutrophilia (sputum neutrophils ≥65% and total cells \>10 million cells/gram) or a positive sputum culture. Specialized stains to identify aspiration (Oil Red O; (3)) and left ventricular dysfunction (Perl's Prussian blue; (4)) will guide swallowing assessment and cardiac work-up, respectively. If a sputum sample is not produced as an outpatient spontaneously, then sputum induction will be pursued 8 weeks after discharge. If there are no sputum samples to guide inhaler regimen, then it will be determined by the study physician guided by the Canadian Thoracic Society guidelines (2) if a sputum-guided regimen has not already been established.
Arms:
Sputum-guided management and comprehensive care management
Usual Care
As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.
Arms:
Usual Care
Size
128
Primary endpoint
Severe exacerbations of COPD
6 months
Eligibility criteria
Inclusion Criteria:
* \>=2 exacerbations of COPD in the last 12-months, FEV1/FVC\<0.7 or radiologic emphysema, with a \>-10 pack-year smoking history
Exclusion Criteria:
* severe mental illness not controlled by medication or life-expectancy less than 6-months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Study personnel (aside from the research coordinator) will be blinded to randomization, sputum biomarker results, and treatment arm. Sputum biomarker results (de-identified) will be available to site leads to optimize treatment.', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
Organization
McMaster University