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 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT03161561
Eligibility Criteria:
COPD Patients Inclusion Criteria:
aged 18-69 GOLD stage I or II have defined exacerbation frequency
Healthy Volunteers Inclusion Criteria:
age and sex matched to recruited COPD patients either non-smokers or smokers with at least 10 years history of smoking at least 10 cigarettes per day.
COPD Patients Exclusion Criteria:
Individuals known to have active malignancy, immunosuppression, diabetes mellitus, chronic kidney disease or hepatic failure.
Individuals with a history of anaemia Individuals who have donated \>200 ml of blood for any reason within the last 6months Individuals who are pregnant or breast feeding. Current participation in any other clinical trial, except those directly relating to this cohort and study.
Inability to communicate in English or convey willingness to participate.
For bronchoscopy - any active lung condition including:
Any active acute lung infection (with the exception of asymptomatic pulmonary colonisation) or malignancy Significant coexisting interstitial lung disease or additional pulmonary diagnosis in addition to COPD Significant interstitial lung disease (on radiological and PFT criteria) Any significant abnormality on CXR that would contraindicate bronchoscopy
Healthy Volunteers Exclusion Criteria:
Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks.
Chronic or acute respiratory disease. Any chronic medical condition or receipt of regular prescription medication other than the oral contraceptive pill.
Individuals who have received a vaccine in the past two weeks. Individuals with a history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range.
Individuals who have donated \>200 ml of blood for any reason within the last 6 months.
Individuals who are pregnant or breast feeding. Current participation in any clinical trial. Inability to communicate in English or convey willingness to participate
For bronchoscopy - any active lung condition including:
Any lung infection Asthma
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT03161561
Study Brief:
Protocol Section:
NCT03161561