A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects

Completed

• Conditions: Asthma; Copd

• Registration Number: NCT00848406
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Smoking induces an inflammatory reaction in the airways which can ultimately result in persistent damage and the development of a Chronic Obstructive Pulmonary Disease (COPD). However, not all subjects who smoke end up with COPD. After long-term smoking, approximately 20% of subjects develop COPD. At this time, it is unclear why some subjects develop COPD, whereas others maintain a normal lung function.

In addition, smoking has important consequences in asthma. Patients with asthma who smoke have a more severe asthma and more often experience an asthma exacerbation. In addition, it has been shown that inhaled corticosteroids are less effective in smoking asthmatics.

With this research project, the researchers will investigate the effects of smoking on the airways. To this end, the researchers will compare markers of airway inflammation, lung function and symptoms between healthy smokers and non-smokers of varying age. In addition, the researchers will compare those healthy subjects with patients with asthma and COPD which are characterized in earlier studies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Study Start: 2009-04
• Primary Completion: 2014-04
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Have not smoked during the last year.
• Have never smoked for as long as a year.
• Have < 0.5 packyear.

Exclusion Criteria

• Persons who used inhaled or oral corticosteroids during >5 years, or within the last 5 years.
• FEV1 <1.2 L
• A subject is not eligible to enter and participate if he does not agree that we inform his general practicioner about participation in the study and also about any unexpected finding during the study.
• Upper respiratory tract infection (e.g. colds), within 2 months.
• Pregnancy, or the possibility of being pregnant (i.e. women who do not use adequate anticonception as judged by the investigator).
• Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
• Signs or symptoms of any other concomitant disease that, in the eyes of the investigator, can interfere with the study results.
• Known recent substance abuse (drug or alcohol).
• Claustrophobia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
parameters for inflammation and remodelling in airway tissue	The duration of the study is estimated on 2 year

Secondary Outcome Measures

Name	Time	Method
Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.	2 year

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands