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

NCT04890938 | Recruiting

• 1 other identifier: 13532
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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

Keywords

COPD; Exacerbation; Comprehensive care management; Sputum

Outcome Measures

Primary Outcomes (1)

• Severe exacerbations of COPD

  As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.

  6 months

Secondary Outcomes (23)

• Moderate COPD Exacerbation

  6 months

• Mild COPD Exacerbation

  6 months

• COPD exacerbation associated with inflammation

  6 months

• Time to first COPD exacerbation associated with inflammation

  6 months

• Time to first COPD exacerbation

  6 months

Study Arms (2)

Sputum-guided management and comprehensive care management

EXPERIMENTAL

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.

Combination Product: Sputum-guided management and comprehensive care management

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Sputum-guided management and comprehensive care management COMBINATION_PRODUCT

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.

Sputum-guided management and comprehensive care management

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=2 exacerbations of COPD in the last 12-months, FEV1/FVC\<0.7 or radiologic emphysema, with a \>-10 pack-year smoking history

You may not qualify if:

• severe mental illness not controlled by medication or life-expectancy less than 6-months

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator
• St. Joseph's Healthcare Hamilton: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

NOT YET RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (4)

• Nici L, ZuWallack R. Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. COPD. 2018 Jun;15(3):223-230. doi: 10.1080/15412555.2018.1501671. Epub 2018 Sep 5.

  PMID: 30183417 BACKGROUND

• Bourbeau J, Bhutani M, Hernandez P, Marciniuk DD, Aaron SD, Balter M, et al. CTS position statement: Pharmacotherapy in patients with COPD-An update. Canadian Journal of Respiratory, Critical Care, and Sleep Medicine. 2017;1(4):222-41.

  BACKGROUND

• Wilson AM, Nair P, Hargreave FE, Efthimiadis AE, Anvari M, Allen CJ; ELVIS Research Study Group. Lipid and smoker's inclusions in sputum macrophages in patients with airway diseases. Respir Med. 2011 Nov;105(11):1691-5. doi: 10.1016/j.rmed.2011.07.011. Epub 2011 Aug 9.

  PMID: 21831624 BACKGROUND

• Leigh R, Sharon RF, Efthimiadis A, Hargreave FE, Kitching AD. Diagnosis of left-ventricular dysfunction from induced sputum examination. Lancet. 1999 Sep 4;354(9181):833-4. doi: 10.1016/S0140-6736(99)80018-X.

  PMID: 10485730 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terence Ho, MB, MSc

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terence N Ho, MB, MSc

CONTACT

9055221155; hot4@mcmaster.ca

Joshua Wald, MD

CONTACT

9055221155; joshua.wald@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: May 27, 2022
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)