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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT02211118
Eligibility Criteria:
Inclusion Criteria:
* Severe COPD (FEV1 30-50% predicted)
* Age 45-70
* American Society of Anesthesiologists (ASA) Class 3
* Body Mass Index \<35 kg/meter squared
* No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)
* Women of non-child bearing age
Exclusion Criteria:
* known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists
* not nothing by mouth (NPO)
* ASA class \>3
* Home oxygen therapy \>2LPM by nasal cannula continuous use
* Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration
* Pregnancy, or possibility of pregnancy
* Coronary heart disease with stable or unstable angina
* Baseline heart rate \<55 beats per minute
* Bradyarrhythmia, heart block, presence of pacemaker
* Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction \<40% by ECHO, MUGA, or myocardial perfusion imaging)
* Cor pulmonale
* Liver disease (hepatic transaminases above the upper limit of normal, cirrhosis, end stage liver disease)
* diagnosis of moderate to severe Obstructive Sleep Apnea
* currently enrolled in any other research study involving drugs or devices
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT02211118
Study Brief:
Protocol Section:
NCT02211118