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 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT03954132
Eligibility Criteria:
Inclusion Criteria:
Patients can be included if all of the following criteria are met:
* Diagnosis of COPD
* Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
* Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* Male or female
* Patients aged ≥40 years of age
* Written informed consent prior to study participation
* The patient is willing and able to follow the procedures outlined in the protocol
Exclusion Criteria:
* Patients with contraindications acc. to SmPC
* Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
* Lack of informed consent
* Pregnant and/or lactating females
* Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
* Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
* Acute respiratory failure (pH \<7,35 and/ or respiratory rate \>30/min within 3 months prior to Visit 1)
* History or current diagnosis of asthma
* History or current diagnosis of asthma-COPD overlap
* History or current diagnosis of allergic rhinitis within the last 5 years
* History or current diagnosis of lung cancer within the last 5 years
* Participation in a parallel interventional clinical trial
* mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
* moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
* severe exacerbation: exacerbation leading to hospitalization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03954132
Study Brief:
Protocol Section:
NCT03954132