Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial

Recruiting

• Conditions: COPD

• Registration Number: NL-OMON28851
• Lead Sponsor: GPRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 316

Inclusion Criteria

Physician diagnosis of COPD (documented obstruction or obstruction measured at the first study visit)
- Age 40 years and older
- Symptomatic (defined as Clinical COPD Questionnaire score ? 1)
- ICS-naive (last 12 months no ICS containing treatment)
- Usage of a long-acting bronchodilator; either usage of a single LABA or LAMA, usage of a single LABA and a single LAMA, or a usage of a single LABA/LAMA inhaler. Patients are allowed to use short-acting bronchodilator.
- Blood eosinophils =100 cells per µL
- One or more characteristics of asthma according to GOLD 2019 (age of onset, pattern of respiratory symptoms, history/family of asthma, history of Atopy).

Exclusion Criteria

- Chronic oral corticosteroid, use more than 60 days in the last 3 months
- Recent exacerbation (last 6 weeks before inclusion)
- Life expectancy of less than 2 years
- Allergy to intervention formulation
- Inability to understand Dutch
- Any other condition which, at the GPs and/or investigator’s discretion, is believed to present a safety risk or may impact the study results
- Patients participating in another ongoing clinical trial that in the investigator’s opinion influences the current study (e.g. another randomized controlled trial)
- In ability to understand and sign the written consent form.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the effectiveness of triple therapy (ICS/LABA/LAMA) on the change in health status, measured with the Clinical COPD Questionnaire (CCQ), in symptomatic ICS-naive COPD patients with characteristics of asthma according to GOLD 2019 (age of onset, pattern of respiratory symptoms, history/family of asthma, history of Atopy) and blood eosinophil counts of =100 cells per µL compared to treatment with dual therapy (LABA/LAMA), within a primary care population. Effectiveness is regarded as difference in the proportion of patients a with minimal clinically improvement on health status (CCQ improvement =0.4) between the study groups.