Study to the effects of using triple therapy on the health status of COPD patients with characteristics of asthma

Phase 1

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

• Registration Number: EUCTR2019-003351-11-NL
• Lead Sponsor: GPRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 short-acting bronchodilator.
- Blood eosinophils =100 cells per µL and one or more characteristics of asthma according to GOLD 2019.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 or Greek
- 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 clinical trial of medicinal product
• Study Design: Not specified