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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT06801951
Eligibility Criteria:
Inclusion criteria COPD subjects:
Ability to walk, sit down and stand up independently
Age 45 - 100 years
Willing to lay in bed for 4 hours during study visits
Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1
Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 \> 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
Shortness of breath on exertion
Willingness and ability to comply with the protocol
Inclusion criteria control subjects:
Healthy male or female according to the investigator's or appointed staff's judgment
Ability to walk, sit down and stand up independently
Age 45 - 100 years
Willing to lay in bed for 4 hours during long study visits
No diagnosis of COPD
Willingness and ability to comply with the protocol
Exclusion Criteria all subjects:
Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
Subjects 86 years and older that fail to get physician eligibility confirmation
Established diagnosis of Insulin dependent diabetes mellitus
Established diagnosis of malignancy
History of untreated metabolic diseases including hepatic or renal disorder
Presence of acute illness or metabolically unstable chronic illness
Presence of fever within the last 3 days
Use of short course of oral corticosteroids within 4 weeks preceding study day
Dietary or lifestyle characteristics:
Use of protein or amino acid containing nutritional supplements within 5 days of first test day
Indications related to interaction with study products:
Known allergy or sensitivity to milk or milk products
Previous injury that could interfere with participation in resistance exercise protocol
Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
(Possible) pregnancy
Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
100 Years
Study:
NCT06801951
Study Brief:
Protocol Section:
NCT06801951