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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COPD, Particulate Matter Induced Inflammation of the Lung

Intervention / Treatment
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* Device: Ectoin Inhalation Solution
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIL05, Inhalation<br> | Device: Ectoin Inhalation Solution<br>* Once daily inhalation of Ectoin Inhalation Solution<br>|
| Placebo Comparator: Placebo, 0,9% NaCl<br> | Device: Placebo<br>* Once daily inhalation of Placebo Inhalation Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD | Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline. | Baseline and 28 days after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | Baseline and 28 days after treatment start | 
| Reduction of lung function decline |  | Baseline and 28 days after treatment start | 
| Quality of life |  | Baseline and 28 days after treatment start | 
| Need for rescue medication |  | 28 days (during treatment phase) | 
| Occurence of adverse events |  | 28 days (during treatment phase) | 
| Lung function parameters |  | 28 days (during treatment phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Particulate Matter induced inflammation of the lung