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

Primary Purpose

COPD, Particulate Matter Induced Inflammation of the Lung

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Ectoin Inhalation Solution

Placebo

About this trial

This is an interventional treatment trial for COPD focused on measuring Particulate Matter induced inflammation of the lung

Eligibility Criteria

75 Years - 80 Years (Older Adult)FemaleDoes not accept 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

Sites / Locations

Institut für umweltmedizinische Forschung

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EIL05, Inhalation

Placebo, 0,9% NaCl

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Vital signs

Reduction of lung function decline

Quality of life

Need for rescue medication

Occurence of adverse events

Lung function parameters

Full Information

NCT ID

NCT01225965

First Posted

October 20, 2010

Last Updated

August 6, 2012

Sponsor

Bitop AG

1. Study Identification

Unique Protocol Identification Number

NCT01225965

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bitop AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Particulate Matter Induced Inflammation of the Lung

Keywords

Particulate Matter induced inflammation of the lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EIL05, Inhalation

Arm Type

Experimental

Arm Title

Placebo, 0,9% NaCl

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Ectoin Inhalation Solution

Intervention Description

Once daily inhalation of Ectoin Inhalation Solution

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Once daily inhalation of Placebo Inhalation Solution

Primary Outcome Measure Information:

Title

Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD

Description

Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.

Time Frame

Baseline and 28 days after treatment start

Secondary Outcome Measure Information:

Title

Vital signs

Time Frame

Baseline and 28 days after treatment start

Title

Reduction of lung function decline

Time Frame

Baseline and 28 days after treatment start

Title

Quality of life

Time Frame

Baseline and 28 days after treatment start

Title

Need for rescue medication

Time Frame

28 days (during treatment phase)

Title

Occurence of adverse events

Time Frame

28 days (during treatment phase)

Title

Lung function parameters

Time Frame

28 days (during treatment phase)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

75 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Institut für umweltmedizinische Forschung

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.iuf.uni-duesseldorf.de/englisch/home-e.htm

Description

Website of the Institut für umweltmedizinische Forschung

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

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