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 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT02386735
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Age ≥40 years
* History of ≥10 pack-years of smoking (past or present smokers)
* Airway obstruction, defined as FEV1/FVC≤70%
* Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following:
* Change of baseline dyspnea
* Change of cough
* Change of sputum quantity or purulence
Exclusion Criteria:
* Diagnosis of asthma
* Initial necessity of hospitalization
* Women who are pregnant or breast feeding
* Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
* Severe coexisting disease with life expectancy \<6 months
* Diagnosis of tuberculosis
* Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
* Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study involving an investigational drug
* Previous enrolment into the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02386735
Study Brief:
Protocol Section:
NCT02386735