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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT04611633
Eligibility Criteria:
Inclusion Criteria:
* Patient has provided written informed consent
* Patient is aged 40 years or older
* Current or ex-smokers with a smoking history ≥ 10 pack years
* Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index \<0.7; baseline or older spirometry)
* Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
* Patient is starting treatment with Trimbow® upon decision by their physician
Exclusion Criteria:
* Patients who are hypersensitive to one of the active substances or excipients
* Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
* Patients on ICS, LABA or LAMA monotherapy
* Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
* Patients participating simultaneously to other clinical trials or studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04611633
Study Brief:
Protocol Section:
NCT04611633