Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT06282861
Eligibility Criteria:
Inclusion Criteria:
* Female or male
* 40-80 yrs. of age
* Current/former smokers ≥10 pack-year
* Diagnosis of COPD according to GOLD 2023 (post-bronchodilator(BD) FEV1/FVC\<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value
* B+ phenotype
* CAT≥10 despite being on LABA-LAMA for ≥3 months, and
* 1 moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and
* ≥150 blood Eos/ μL (as determined by a single Eos measurement in the previous 12 months available in the medical record of the patient)
* A signed and dated written informed consent prior to study participation.
Exclusion Criteria:
* GOLD E (≥2 moderate or 1 severe ECOPD in the previous year)
* ICS treatment (or oral steroid for whatever reason) during the last 8 weeks (10)
* ECOPD during the last 8 weeks
* Current diagnosis of asthma or documented history of asthma in the medical record of the patient according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines
* Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm)
* Use of domiciliary long-term oxygen therapy or non-invasive ventilation
* Alpha-1 antitrypsin deficiency
* Unstable or life-threatening cardiac disease, including:
* Myocardial infarction or unstable angina in the last 6 months
* Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
* New York Heart Association (NYHA) Class IV Heart failure.
* Participation on Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study.
* Long term antibiotic therapy (antibiotics are allowed for the short-term treatment of an exacerbation or for short term treatment of other acute infections during the study).
* Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study).
* Active neoplasm
* Life expectancy \< 1 yr.
* Current participation in other RCTs (randomized clinical trial)
* Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures.
* Any disease, disability, or geographic location that would limit compliance for scheduled visits.
* Known allergy to Trelegy® components (vilanterol, umeclidinium and/or fluticasone furoate) or inability to use the Ellipta® device.
* Women who are pregnant or lactating or are planning to become pregnant during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06282861
Study Brief:
Protocol Section:
NCT06282861