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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00848406
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : January 16, 2015
Information provided by (Responsible Party):
Maarten van den Berge, 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.

Condition or disease
Asthma Copd

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Study Type : Observational
Estimated Enrollment : 120 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.

Primary Outcome Measures :
  1. parameters for inflammation and remodelling in airway tissue [ Time Frame: The duration of the study is estimated on 2 year ]

Secondary Outcome Measures :
  1. Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan. [ Time Frame: 2 year ]

Biospecimen Retention:   Samples With DNA
Blood, induced sputum, bronchial biopsies, brush and lining fluid, urine

Information from the National Library of Medicine

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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
Study Population
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.

Information from the National Library of Medicine

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

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University Medical Centre Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: Maarten van den Berge, MD, PhD University Medical C enter Groningen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maarten van den Berge, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00848406    
Other Study ID Numbers: METc2009007
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015
Keywords provided by Maarten van den Berge, University Medical Center Groningen:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases