Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
NCT ID: NCT01225965
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2010-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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EIL05, Inhalation
Ectoin Inhalation Solution
Once daily inhalation of Ectoin Inhalation Solution
Placebo, 0,9% NaCl
Placebo
Once daily inhalation of Placebo Inhalation Solution
Interventions
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Ectoin Inhalation Solution
Once daily inhalation of Ectoin Inhalation Solution
Placebo
Once daily inhalation of Placebo Inhalation Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
80 Years
FEMALE
No
Sponsors
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Bitop AG
INDUSTRY
Responsible Party
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Locations
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Institut für umweltmedizinische Forschung
Düsseldorf, , Germany
Countries
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Related Links
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Website of the Institut für umweltmedizinische Forschung
Other Identifiers
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PPL-015
Identifier Type: -
Identifier Source: org_study_id