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

COPD Clinical Trial

— EFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225965
• Other study ID #: PPL-015
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: August 6, 2012
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Inflammation
• Particulate Matter Induced Inflammation of the Lung

Intervention

Device:
• Ectoin Inhalation Solution
Once daily inhalation of Ectoin Inhalation Solution
• Placebo
Once daily inhalation of Placebo Inhalation Solution

Locations

Country	Name	City	State
Germany	Institut für umweltmedizinische Forschung	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Vital signs		Baseline and 28 days after treatment start	Yes
Secondary	Reduction of lung function decline		Baseline and 28 days after treatment start	Yes
Secondary	Quality of life		Baseline and 28 days after treatment start	No
Secondary	Need for rescue medication		28 days (during treatment phase)	Yes
Secondary	Occurence of adverse events		28 days (during treatment phase)	Yes
Secondary	Lung function parameters		28 days (during treatment phase)	Yes

External Links

•   Website of the Institut für umweltmedizinische Forschung