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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00132860
Eligibility Criteria:
Inclusion Criteria:
* Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
* Current or ex-smoker
* Postbronchodilator FEV1 \< 60% in stable condition (\> 4 weeks after hospitalisation)
* \< 300 ml bronchodilator reversibility in FEV1
Exclusion Criteria:
* Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
* Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
* Patients with pulmonary malignancy
* Patients with other pulmonary diseases than COLD.
* Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
* Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
* Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
* Patients with known allergy or intolerance to azithromycin
* Pregnant or breastfeeding women
* Manifest heart, liver or renal insufficiency
* Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00132860
Study Brief:
Protocol Section:
NCT00132860