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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014