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 @ 4:39 AM
Ignite Modification Date:
2025-12-25 @ 4:39 AM
NCT ID:
NCT03279718
Eligibility Criteria:
Inclusion Criteria:
COPD functional class B to D (moderate to very severe) according to the Global Initiative For Chronic Obstructive Lung Disease (GOLD)
* age ≥ 40 and ≤ 80 years
* at least 10 natural teeth
* COPD-associated hsCRP elevation (after exclusion of infection) with hsCRP \> 3mg/l
* presence of chronic periodontitis
* at least 1 exacerbation leading to treatment with systemic glucocorticoids or antibiotics or hospitalization within the last 12 months
* non-smoker or ex-smoker for at least the last 6 months
* ability to understand the character and individual consequences of participation in this trial and to give written informed consent
* provision of a written informed consent to participation in the trial prior to trial start and any trial-related procedures
Exclusion Criteria:
* any subgingival root-planing or any kind of periodontal surgery within the last 6 months (professional tooth cleaning is allowed)
* any antibiotics and/or systemic corticosteroid medication in the last 4 weeks before inclusion
* any antibiotics needed as prophylaxis or as an adjunct to periodontal treatment
* diagnostical bronchoscopy within the last 8 weeks
* any kind of bronchoscopy and lung surgery (volume reduction, transplantation, pneumonectomy) within the last 6 months
* concurrent participation in any interventional clinical trial (observational trials are allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03279718
Study Brief:
Protocol Section:
NCT03279718