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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01693003
Eligibility Criteria:
Inclusion Criteria:
* Men and women (neither pregnant nor nursing women) ≥40 years of age, with a history of smoking (\>20 years/pack) and COPD diagnosis according to GOLD criteria.
* Post-bronchodilator FEV1 \>50% and \<80%, and FEV1/FVC ≤70% of predicted value.
Exclusion Criteria:
* Hospital admission due to COPD exacerbation or lung infection in the 6 weeks prior to screening, diagnosis of current or previous bronchial asthma, history of allergic rhinitis or other atopic diseases, or peripheral eosinophilia \>400/mm3.
* Inability to discontinue the usual bronchodilator therapy prior to initial screening tests, need for continuous oxygen therapy, or arterial oxygen saturation \<85% at rest, or history of adverse reactions to sympathomimetic amines or use of inhaled medication.
* Anemia, hypo- or hyperthyroidism, hyperadrenergic conditions, uncontrolled insulin-dependent diabetes mellitus, malignancy, or any disease or condition that limits exercise capacity other than COPD.
* History of drug or alcohol abuse, poor adherence to drug treatment, or treatment with any investigational drug in the month before screening.
* Patients with ventricular arrhythmia.
* Patients with \<80% oxyhemoglobin saturation during exercise testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01693003
Study Brief:
Protocol Section:
NCT01693003