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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03114969
Eligibility Criteria:
Inclusion Criteria:
* Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy.
* Aged \>=40 years of age at inclusion.
* Using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study.
* Males or females.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
Exclusion Criteria:
* Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
* Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse history at screening (Visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
* Investigational product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five half-lives of the investigational drug, whichever is longer.
* Investigational product: Subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03114969
Study Brief:
Protocol Section:
NCT03114969