Studies of induced immune responses in smokers

Endotoxin-induced immune response in the lower respiratory tract in smokers with and without chronic bronchitis (CB) and / or chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023681-45-SE

Enrollment

100

Registered

2011-02-24

Start date

2012-05-04

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway inflammation in smokers with and without COPD and / or CB

Interventions

Product Name: Endotoxin Product Code: E-solution Pharmaceutical Form: Endotracheopulmonary instillation, powder for solution INN or Proposed INN: endotoxin CAS Number: 11034-88-1 Concentration unit: n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 40-75, smokers / non smokers no regular medication (except birth control pills and antidepressants) no chronic disease other than CB or COPD informed consent BMI / weight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: asthma, atopy, eczema, cardiovascular disorders pregnancy, regular medication snuff, chewing tobacco current participation in other studies chronic disease other than COPD / CB BMI / weight diabetes allergic reaction against ketobemidone, midazolam or lidocaine

Design outcomes

Primary

Measure	Time frame
Main Objective: Analyse the immune response caused by local endotoxinexposure in the airways and blood of smokers with and without CB and / or COPD and to identify differences from healthy never-smokers ;Secondary Objective: To identify cellular and molecular targets for new drug treatment for chronic respiratory disease ;Primary end point(s): Cell content of the BAL fluid, changes in inflammtory cells and mediators in airways ;Timepoint(s) of evaluation of this end point: All samples will be analyzed immediately after bronchoscopy 1 and 2.	—

Measure

Time frame

Main Objective: Analyse the immune response caused by local endotoxinexposure in the airways and blood of smokers with and without CB and / or COPD and to identify differences from healthy never-smokers ;Secondary Objective: To identify cellular and molecular targets for new drug treatment for chronic respiratory disease ;Primary end point(s): Cell content of the BAL fluid, changes in inflammtory cells and mediators in airways ;Timepoint(s) of evaluation of this end point: All samples will be analyzed immediately after bronchoscopy 1 and 2.

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Secondary

Measure	Time frame
Secondary end point(s): Changes in the inflammatory cells and the mediators the blood. ;Timepoint(s) of evaluation of this end point: All samples will be analyzed immediately after bronchoscopy 1 and 2.	—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026