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

August 6, 2012 updated by: Bitop AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Institut für umweltmedizinische Forschung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

73 years to 78 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EIL05, Inhalation
Device: Ectoin Inhalation Solution
Once daily inhalation of Ectoin Inhalation Solution
Placebo Comparator: Placebo, 0,9% NaCl
Device: Placebo
Once daily inhalation of Placebo Inhalation Solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs
Time Frame: Baseline and 28 days after treatment start
Baseline and 28 days after treatment start
Reduction of lung function decline
Time Frame: Baseline and 28 days after treatment start
Baseline and 28 days after treatment start
Quality of life
Time Frame: Baseline and 28 days after treatment start
Baseline and 28 days after treatment start
Need for rescue medication
Time Frame: 28 days (during treatment phase)
28 days (during treatment phase)
Occurence of adverse events
Time Frame: 28 days (during treatment phase)
28 days (during treatment phase)
Lung function parameters
Time Frame: 28 days (during treatment phase)
28 days (during treatment phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPL-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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