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
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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
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Have not smoked during the last year.
- Have never smoked for as long as a year.
- Have < 0.5 packyear.
- 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).
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|
|Responsible Party:||Maarten van den Berge, Dr., University Medical Center Groningen|
|Other Study ID Numbers:||
|First Posted:||February 20, 2009 Key Record Dates|
|Last Update Posted:||January 16, 2015|
|Last Verified:||January 2015|
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases