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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00848406
Acronym
NORM
Enrollment
120
Registered
2009-02-20
Start date
2009-04-30
Completion date
2015-01-31
Last updated
2015-01-16

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

Conditions

Asthma, Copd

Keywords

bronchial, COPD, Asthma, sputum, biopsies

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.

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
parameters for inflammation and remodelling in airway tissueThe duration of the study is estimated on 2 year

Secondary

MeasureTime frame
Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.2 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026