A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects (NORM)
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|ClinicalTrials.gov Identifier: NCT00848406|
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : January 16, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||An Observational Study to Obtain Normal Values of Inflammatory Variables in Induced Sputum, Exhaled Breath, and Bronchial Biopsies From Healthy Smoking and Non-smoking Individuals|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||January 2015|
30 individuals ≤ 40 years, who currently smoke ≥ 10 cigarettes/day and > 10 packyears
30 individuals ≤ 40 years, who have not smoked during the last year, have never smoked for as long as a year (i.e. at least one cigarette per day or one cigar per week, AND have < 0.5 packyear.
30 individuals above 40 years, who currently smoke ≥ 10 cigarettes per day, and > 20 packyears.
30 individuals above 40 years, who have not smoked during the last year, have never smoked for as long as a year, and have < 0.5 packyear.
- parameters for inflammation and remodelling in airway tissue [ Time Frame: The duration of the study is estimated on 2 year ]
- Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan. [ Time Frame: 2 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848406
|University Medical Centre Groningen|
|Groningen, Netherlands, 9713GZ|
|Principal Investigator:||Maarten van den Berge, MD, PhD||University Medical C enter Groningen|