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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05114434
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults aged ≥40 years;
* Signed informed consent;
* Current or ex-smokers with a smoking history of at least 10 pack years. An ex smoker will be defined as a subject who has not smoked for ≥ 6months at screening;
* Diagnosis of COPD according to the International Statement;
* COPD patients with a forced expiratory volume in the 1st second (FEV1) between 30% and 80% of predicted post-bronchodilator (salbutamol 400 µg) at baseline visit;
* COPD patients with lung hyperinflation with residual volume (RV) ≥ 120% predicted;
* COPD patients treated with ICS/LABA or LABA/LAMA or ICS/LAMA therapy from at least one month before baseline visit;
* COPD patients with elevated impact of disease and/or symptoms defined by a CAT≥ 10 score and/or a mMRC ≥ 2 score and an history of exacerbation (≥ 1 exacerbation in the previous year).
Exclusion Criteria:
* Patients with COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 4 weeks prior to enrolment;
* Patients with concomitant other lung disease (e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, pulmonary hypertension);
* Patients requiring long-term oxygen therapy (LTOT) ≥12 h a day on a daily basis for chronic hypoxemia;
* Patients with severe comorbidities associated to COPD, such as unstable cardiovascular diseases or cancer;
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH), bladder-neck obstruction, moderate to severe renal impairment or urinary retention. BPH patients who are stable on treatment will be considered for enrolment;
* Patients with clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment;
* COPD patients treated with triple LABA/LAMA/ICS therapy;
* Pregnant women;
* Subjects unable to meet the criteria of acceptability and repeatability of pulmonary function tests, according to the American Thoracic Society/European Respiratory Society (ATS/ERS) document.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05114434
Study Brief:
Protocol Section:
NCT05114434