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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT01225965
First received: October 20, 2010
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
COPD
Particulate Matter Induced Inflammation of the Lung
 Device: Ectoin Inhalation Solution
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Bitop AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.


Secondary Outcome Measures:
  • Vital signs [ Time Frame: Baseline and 28 days after treatment start ] [ Designated as safety issue: Yes ]
  • Reduction of lung function decline [ Time Frame: Baseline and 28 days after treatment start ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Baseline and 28 days after treatment start ] [ Designated as safety issue: No ]
  • Need for rescue medication [ Time Frame: 28 days (during treatment phase) ] [ Designated as safety issue: Yes ]
  • Occurence of adverse events [ Time Frame: 28 days (during treatment phase) ] [ Designated as safety issue: Yes ]
  • Lung function parameters [ Time Frame: 28 days (during treatment phase) ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225965

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

Additional Information:
Website of the Institut für umweltmedizinische Forschung  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT01225965     History of Changes
Other Study ID Numbers: PPL-015
Study First Received: October 20, 2010
Last Updated: August 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013