Status:

NOT_YET_RECRUITING

Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?

Lead Sponsor:

Ottawa Hospital Research Institute

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

Conditions:

Chronic Obstructive Pulmonary Disease

COPD

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

The goal of this clinical trial is to see if the use of two simple blood tests: C reactive protein and eosinophils, can reduce the use of steroids and antibiotics in patients with flares of chronic ob...

Detailed Description

Study design: randomized, controlled, feasibility trial Population: Adult patients with a physician diagnosis of COPD suffering from an acute exacerbation of COPD Intervention: Recommendations for a...

Eligibility Criteria

Inclusion

  • Outpatients with a known diagnosis of COPD (must have prior spirometry documenting FEV1/FVC post-bronchodilator \< 0.7 or documented respirologist-diagnosis of COPD)
  • Presenting with AECOPD, defined as an increase in respiratory symptoms necessitating an increase in medications
  • Consent provided

Exclusion

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • new infiltrate on chest x-ray day of randomization
  • temperature ≥ 38.0 ◦C taken orally day of randomization
  • positive blood culture day of randomization
  • co-morbid asthma or severe bronchiectasis
  • acute heart failure day of randomization
  • known immunosuppression including the use of chronic glucocorticoids day of randomization
  • allergy/absolute contraindication to the use of oral steroids
  • planned pregnancy or currently pregnant
  • COVID positive

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06929767

Start Date

September 1 2025

End Date

October 1 2026

Last Update

April 16 2025

Active Locations (1)

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1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6