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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225965
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
Bitop AG

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.

Condition or disease Intervention/treatment
COPD Particulate Matter Induced Inflammation of the Lung Device: Ectoin Inhalation Solution Device: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2010
Primary Completion Date : February 2011
Study Completion Date : September 2011

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: Baseline and 28 days after treatment start ]
  2. Reduction of lung function decline [ Time Frame: Baseline and 28 days after treatment start ]
  3. Quality of life [ Time Frame: Baseline and 28 days after treatment start ]
  4. Need for rescue medication [ Time Frame: 28 days (during treatment phase) ]
  5. Occurence of adverse events [ Time Frame: 28 days (during treatment phase) ]
  6. Lung function parameters [ Time Frame: 28 days (during treatment phase) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 80 Years   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225965

Institut für umweltmedizinische Forschung
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Bitop AG

Additional Information:
Responsible Party: Bitop AG Identifier: NCT01225965     History of Changes
Other Study ID Numbers: PPL-015
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by Bitop AG:
Particulate Matter induced inflammation of the lung

Additional relevant MeSH terms:
Pathologic Processes
Pharmaceutical Solutions