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Can a simple inhalation tame lung inflammation in older women?

NCT ID NCT01225965

Disease control Sponsor: Bitop AG Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether inhaling a solution containing ectoin, a natural substance, can reduce inflammation in the lungs and help prevent further loss of lung function. It involved 36 postmenopausal women aged 75–80 with mild airway obstruction and signs of inflammation. Participants used the inhaler for a period, and researchers measured changes in inflammatory markers and lung function over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Start date

Oct 2010

Finished

Sep 2011

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset pneumonitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD Particulate matter induced inflammation of the lung

Contacts and locations

Locations

  • Institut für umweltmedizinische Forschung

    Düsseldorf, 40225, Germany

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