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

Not Applicable

Completed

• Conditions: COPD; Particulate Matter Induced Inflammation of the Lung
• Interventions: Device: Ectoin Inhalation Solution; Device: Placebo

• Registration Number: NCT01225965
• Lead Sponsor: Bitop AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Primary Completion: 2011-02
• Study Completion: 2011-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EIL05, Inhalation	Ectoin Inhalation Solution	-
Placebo, 0,9% NaCl	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Institut für umweltmedizinische Forschung; 🇩🇪 Duesseldorf, Germany