Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04890938

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

About this study

STRIVE is a randomized-controlled trial comparing a two-pronged intervention, including sputum-biomarker-directed treatment of airway inflammation, and comprehensive care management, to usual care, for COPD patients with frequent exacerbation from two sites.

The intervention consists of 6-months of comprehensive care management (CCM) and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits will occur at 2, 6 and 16 weeks after hospital discharge. For the intervention group, the key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Spontaneous sputum biomarkers will be used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

  1. Severe exacerbations of COPD

    Time frame: 6 months

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

Secondary outcomes

  1. Moderate COPD Exacerbation

    Time frame: 6 months

    as defined by worsening of symptoms requiring the use of antibiotics or steroids without ER visit or hospitalization

  2. Mild COPD Exacerbation

    Time frame: 6 months

    Defined as worsening of symptoms that were self-managed and resolved without systemic steroids or antibiotics; captured by Clinical COPD Questionnaire

  3. COPD exacerbation associated with inflammation

    Time frame: 6 months

    Defined as an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture

  4. Time to first COPD exacerbation associated with inflammation

    Time frame: 6 months

    Defined as time to an exacerbation (as defined previously) with an abnormal sputum cell count or sputum culture

  5. Time to first COPD exacerbation

    Time frame: 6 months

    Defined as time to an exacerbation (as defined previously)

  6. Change in Clinical COPD Questionnaire

    Time frame: 26 weeks

    Change in Clinical COPD Questionnaire between Week 0 and Week 26.

  7. Change in COPD Assessment Test

    Time frame: 26 weeks

    Change in COPD Assessment Test between Week 0 and Week 26.

  8. Change in Patient Health Questionnaire-9

    Time frame: 26 weeks

    Change in Patient Health Questionnaire-9 between Week 0 and Week 26.

  9. Change in General Anxiety Disorder-7 questionnaire

    Time frame: 26 weeks

    Change in General Anxiety Disorder-7 questionnaire between Week 0 and Week 26.

  10. EQ-5D-5L questionnaire

    Time frame: 26 weeks

    Change in EQ-5D-5L between Week 0 and Week 26.

  11. FEV1

    Time frame: 16 weeks

    Change in FEV1 between clinic visits 1 and 3.

  12. Sputum eosinophil percentage

    Time frame: 16 weeks

    Change in sputum eosinophil percentage between clinic visits 1 and 3

  13. Sputum neutrophil count

    Time frame: 16 weeks

    Change in sputum neutrophil count between clinic visits 1 and 3

  14. Sputum abnormalities rectified

    Time frame: 16 weeks

    The number of subjects who have their sputum abnormalities rectified will be recorded between clinics 1 and 3

  15. Use of oral or inhaled corticosteroid

    Time frame: 6 months

    Cumulative dose of oral and inhaled corticosteroid

  16. Use of antibiotics

    Time frame: 6 months

    Cumulative courses of oral or intravenous antibiotics

  17. Participant recruitment number

    Time frame: 2 years

    number of patients approached for recruitment during study

  18. Reason for non-participation

    Time frame: 2 years

    reasons for non-participation during recruitment period

  19. Clinic attendance

    Time frame: 6 months

    Number of clinic visits attended while enrolled in the study

  20. Number of days to visit 1

    Time frame: Should fall within a 2-3 week window

    number of days to visit 1 from hospital discharge

  21. Number of clinic visits

    Time frame: 6 months

    Number of clinic visits patients attend during the 6 months that they are participating in the study

  22. Patient care

    Time frame: study duration

    number of nursing telephone calls initiated by the patient, number of adequate sputum samples collected, and the number referred to a smoking cessation program

  23. Side effects

    Time frame: 26 weeks

    Side effects will be captured by noting peak serum glucose levels and blood pressure measured in-hospital, and the occurrence of psychosis, candidiasis, C. difficile infection, and gastrointestinal upset as reported by the patient during clinic visits

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Wald, MD

CONTACT

[email protected]

9055221155 ext. 37036

Terence N Ho, MB, MSc

CONTACT

[email protected]

9055221155 ext. 32995

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Academic Health Sciences Organization
  • Hamilton Health Sciences Corporation
  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial

Acronym: STRIVE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 18, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.