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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT02039050
Eligibility Criteria:
Inclusion Criteria:
* Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
* On inhaled corticosteroids / long-acting beta agonists
* FEV1 30-80% predicted and FEV1/FVC \<70%.
* Smoking history ≥10 pack-years.
* Ability to give informed consent
* Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being
Exclusion Criteria:
* Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
* A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
* Any clinically significant medical condition that may endanger the health or safety of the participant
* Known or suspected sensitivity to/intolerance of investigational medicinal product
* Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
* Pregnancy or lactation
* Unable to comply with the procedures of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02039050
Study Brief:
Protocol Section:
NCT02039050