Status:
COMPLETED
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
Lead Sponsor:
Bitop AG
Conditions:
COPD
Particulate Matter Induced Inflammation of the Lung
Eligibility:
FEMALE
75-80 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01225965
Start Date
October 1 2010
End Date
September 1 2011
Last Update
August 7 2012
Active Locations (1)
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1
Institut für umweltmedizinische Forschung
Düsseldorf, Germany, 40225