Sputum-guided Treatment With Comprehensive Care Management in COPD - A Randomized-controlled Trial

Summary

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.

Conditions

• COPD

Interventions

COMBINATION_PRODUCT

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.

OTHER

Usual Care

As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.

Sponsors & Collaborators

• Hamilton Academic Health Sciences Organization

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• McMaster University

  lead OTHER

Principal Investigators

• Terence Ho, MB, MSc · St. Joseph's Healthcare Hamilton

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-27

Primary Completion

2025-03-31

Completion

2025-08-31

Countries

• Canada

Study Locations