Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung

An Efficacy and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution (EIL) in Subjects With Inflammation and Airway Obstruction Followed by a Long Term Study Extension on the Prevention of Lung Function Decline

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.

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