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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT02619357
Eligibility Criteria:
Inclusion Criteria:
* Cohort 1 (COPD) \>=45 years and \<=70 years
* Cohort 2 (Asthma) \>=18 years and \<=70 years.
* Cohort 1; subjects with a confirmed diagnosis of COPD (Gold stage 2 and 3, COPD patients will be classified according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines) as defined by post-bronchodilator spirometry FEV1 \>=40% and \<80% predicted, and FEV1/FVC \<0.7
* Cohort 2; subjects with documented, physician-diagnosed asthma.
* BMI within the range 19 to 32 kilogram(kg)/m\^2 (inclusive)
* Male or female; A female of childbearing potential is eligible to enter and participate in the study if she has a negative pregnancy test at screening and day 1.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
* Women who are pregnant or lactating or are planning on becoming pregnant during the study.
* Alpha1-antitrypsin deficiency: Subjects with a diagnosis of alpha1-antitrypsin deficiency as the underlying cause of COPD, if known.
* Other respiratory disorders: Subjects with tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* Pneumonia or other respiratory tract infection that has not resolved at least 14 days prior to screening. In addition, any subject that experiences pneumonia during any period between the screening visit and the study visit will be excluded.
* COPD or asthma exacerbation (in this case defined as a change in symptoms requiring increased doses of current medicines or the prescription of new medicines, e.g., corticosteroids or antibiotics) that has not resolved at least 28 days prior to screening. COPD or asthma exacerbation during any period between the screening visit and the study visit will be excluded.
* Presence of severe and/or poorly controlled asthma that in the opinion of the investigator renders participation in the study unsafe
* Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing: orthopaedic, neurological, cardiovascular or other complaints that significantly impair normal biomechanical movement patterns and limit the ability to walk/cycle as judged by the investigator.
* Resting oxyhemoglobin saturation \<94%.
* Use of supplemental oxygen therapy during the day or night.
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol (males \>21 units per week and females \>14 units per week) or drug abuse within the last 2 years. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (\~240 milliliter \[mL\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* Inability to abstain from smoking during the period in which the subject is admitted to the Clinical Unit.
* A history of allergy or hypersensitivity to metal, particularly stainless steel.
* Clinically significant abnormality on electrocardiogram (ECG) as determined by the investigator.
* Any vital sign indicator, e.g., hypertension or tachycardia at rest that at the discretion of the investigator would make participation in the study unsafe or unfeasible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02619357
Study Brief:
Protocol Section:
NCT02619357