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Completed

NCT Number: NCT01225965

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Particulate Matter Induced Inflammation of the Lung Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

75 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut für umweltmedizinische Forschung

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ectoin Inhalation Solution

Device

Once daily inhalation of Ectoin Inhalation Solution

PLACEBO

Device

Once daily inhalation of Placebo Inhalation Solution

Primary outcomes

  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 outcomes

  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. Change in 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)

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study 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

Acronym: EFECT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2010
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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