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

NCT01225965 | Completed DMC

• 1 other identifier: PPL-015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Particulate Matter Induced Inflammation of the Lung

Keywords

Particulate Matter induced inflammation of the lung

Outcome Measures

Primary Outcomes (1)

• Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD

  Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.

  Baseline and 28 days after treatment start

Secondary Outcomes (6)

• Vital signs

  Baseline and 28 days after treatment start

• Reduction of lung function decline

  Baseline and 28 days after treatment start

• Change in Quality of life

  Baseline and 28 days after treatment start

• Need for rescue medication

  28 days (during treatment phase)

• Occurence of adverse events

  28 days (during treatment phase)

Study Arms (2)

EIL05, Inhalation

EXPERIMENTAL

Device: Ectoin Inhalation Solution

Placebo, 0,9% NaCl

PLACEBO COMPARATOR

Device: Placebo

Interventions

Placebo DEVICE

Once daily inhalation of Placebo Inhalation Solution

Placebo, 0,9% NaCl

Ectoin Inhalation Solution DEVICE

Once daily inhalation of Ectoin Inhalation Solution

EIL05, Inhalation

Eligibility Criteria

• Age: 75 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

Institut für umweltmedizinische Forschung

Düsseldorf, 40225, Germany

Location

Related Links

• Website of the Institut für umweltmedizinische Forschung

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (1)