Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of… (NCT01225965) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
Germany36 participantsStarted 2010-10
Plain-language summary
To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.
Who can participate
Age range75 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal females (75 - 80 years)
* FEV1/FVC \< 0,77 (in the investigation 2007/2008)
* Inflammatory markers TFN-alpha \> median or neutrophilic granulocytes \> median (investigation 2007/2008)
* Non smokers or ex smokers who have stopped smoking for longer than 6 months
Exclusion Criteria:
* Participation in another clinical study in the previous month
* Severe concomitant disease which may have an impact on the study participation
* Hypersensitivity against Ectoin
* Myocardial infarction or apoplexy within the last year
* Uncontrolled hypertension: systolic blood pressure \>200 mmHg or diastolic pressure \>120 mmHg
* Known aortic aneurysm
* Other respiratory diseases (e.g. cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, allergic alveolitis, tuberculosis, etc.)
* Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit)
* on investigators decision
What they're measuring
1
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
Timeframe: Baseline and 28 days after treatment start