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

Phase 4

Completed

Conditions: COPD
10006436

Registration Number: NL-OMON54789

Lead Sponsor: GPRI

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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 AND one or more characteristics of asthma
according to GOLD 2019.

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)
- Inability to understand and sign the written consent form

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is the difference in the proportion of<br /><br>patients with a clinically relevant improvement in health status (>=0.4<br /><br>improvement on the CCQ) between the triple therapy group and LABA/LAMA<br /><br>treatment groups at the end of the 26 weeks intervention period. All main<br /><br>analyses will be conducted intention-to-treat.</p><br>

Secondary Outcome Measures