Acute and chronic inflammatory responses induced by smoking in individuals being susceptible and non-susceptible for development of COPD: from specific disease phenotyping towards novel made therapy (study 1).

Completed

• Conditions: chronic ibstructive brochitis( COPD); emphysema; 10010613

• Registration Number: NL-OMON31923
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

• Age 18-75 years
• Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups of table 4.1
• Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour
• Physically and mentally able to undergo the total study protocol
• Written informed consent

Exclusion Criteria

• Participation in another study
• Alpha-1-antitrypsin deficiency
• Selected grade 1-3 co-morbidity listed in the ACE-27
• Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
• Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc
• Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis
• Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc
• Medication that may affect the results of the study: NSAID*s, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Sintrom tablets

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Local inflammation before and after cigarette smoking assessed by exhaled<br /><br>breath condensate, microprobe sampling and bronchial biopsies.<br /><br>• Systemic inflammation before and after cigarette smoking assessed by the<br /><br>expression of established and newly developed markers on innate immune cells<br /><br>associated with pre-activation.<br /><br>• Extensive clinical characterisation including life style factors, lung<br /><br>function, CT scanning of the lung.<br /><br>• Corticosteroid responsiveness of epithelial cells in vitro.<br /><br>• Distribution of candidate genes (SNPs) for COPD between the 5 different<br /><br>groups and associations with the inflammatory responses on acute smoking. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>