TRACkER trial

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-508300-37-00
• Lead Sponsor: General Practitioners Research Institute B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-21
• Study Completion: 2024-02-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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 a 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, except for prescriptions during a Covid infection, Recent exacerbation (last 6 weeks before inclusion), Life expectancy of less than 2 years, Allergy to intervention formulation, Inability to understand national language., Any other condition which, at the physician’s 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 clinical trial of medicinal product
• Study Design: Not specified