Recruiting

Sputum-guided Treatment

Sponsor:

McMaster University

Code:

NCT04890938

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Sputum-guided management and comprehensive care management

Usual Care

Study Details

Brief 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

Study ID

NCT04890938

Start date

May 27, 2022

Status verified date

Nov, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sputum-guided management and comprehensive care management

The intervention consists of 6-months of CCM and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits at 2, 6, and 16 weeks. The key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Clinic nurse will review inhaler technique with the patient. Sputum (spontaneous) biomarkers will be measured with results used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge, at both sites.

active comparator: Usual Care

This group will also receive clinic visits at 2, 6, and 16 weeks with a study physician, and also education material, inhaler technique assessment and education, and case management from the clinic personnel. The study physician will pursue further investigation and/or further intervention if they see fit.

Interventions

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.

Usual Care

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

Primary outcome measure

  • Severe exacerbations of COPD [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Terence N Ho, MB, MSc

9055221155hot4@mcmaster.ca

Joshua Wald, MD

9055221155joshua.wald@medportal.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Terence Ho, MB MSc

9055221155hot4@mcmaster.ca

Principal Investigator:

Terence Ho, MB MSc

More Information

Sponsor

McMaster University

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Keywords

  • COPD
  • Exacerbation
  • Comprehensive care management
  • Sputum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-11-21.