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:
NCT01701869
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.
* Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). \[GOLD, 2009\] with FEV1 of \>80% (mild COPD) or \>50% but ≤80% (moderate COPD) of predicted normal and FEV1/FVC\<0.7
* Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging \[GOLD, 2009\].
* Subjects have a current or prior history of ≥10 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
* Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation.
Exclusion Criteria:
* Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer).
* Subjects having undergone lung surgery
* Subject has a α1-antitrypsin deficiency as underlying cause of COPD.
* Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute AECOPD or pneumonia has resolved).
* Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.
* Subject has other conditions that the principal investigator judges may interfere with the study findings, such as:
* Subject at risk of noncompliance, or unable to comply with the study procedures.
* Evidence of alcohol or drug abuse.
* Others, as per clinical judgement
* Women who are pregnant or lactating or are planning on becoming pregnant during the study \*\*If subject has any ONE of the above exclusion they cannot be enrolled into the study\*\*
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT01701869
Study Brief:
Protocol Section:
NCT01701869