A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects (NORM)
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Purpose
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 |
|---|
|
Asthma Copd |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- parameters for inflammation and remodelling in airway tissue [ Time Frame: The duration of the study is estimated on 2 year ] [ Designated as safety issue: Yes ]
- Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood, induced sputum, bronchial biopsies, brush and lining fluid, urine
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
30 individuals ≤ 40 years, who currently smoke ≥ 10 cigarettes/day and > 10 packyears
|
|
2
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.
|
|
3
30 individuals above 40 years, who currently smoke ≥ 10 cigarettes per day, and > 20 packyears.
|
|
4
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Healthy individuals
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.
Contacts and Locations| Contact: Maarten van den Berge, MD, PhD | +31-50-3615260 | m.van.den.berge@int.umcg.nl |
| Netherlands | |
| University Medical Centre Groningen | Recruiting |
| Groningen, Netherlands, 9713GZ | |
| Contact: Maarten van den Berge, MD, PhD +31-50-3615260 m.van.den.berge@int.umcg.nl | |
| Principal Investigator: Maarten van den Berge, MD. PhD | |
| Principal Investigator: | Maarten van den Berge, MD, PhD | University Medical C enter Groningen |
More Information
No publications provided
| Responsible Party: | Maarten van den Berge, Dr., University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00848406 History of Changes |
| Other Study ID Numbers: | METc2009007 |
| Study First Received: | February 19, 2009 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Netherlands: Independent Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Netherlands: Dutch Health Care Inspectorate Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by University Medical Centre Groningen:
|
bronchial COPD Asthma sputum biopsies |
Additional relevant MeSH terms:
|
Asthma Pulmonary Disease, Chronic Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013