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

Bitop

Status

Completed

Conditions

COPD

Particulate Matter Induced Inflammation of the Lung

Treatments

Device: Ectoin Inhalation Solution

Device: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01225965

PPL-015

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Female

Ages

75 to 80 years old

Volunteers

No Healthy Volunteers

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