A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects - Full Text View

Sponsored by:	University Medical Centre Groningen
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00848406

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:	Cohort, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood, induced sputum, bronchial biopsies, brush and lining fluid, urine

Estimated Enrollment:	120
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (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

Study Population

Healthy individuals

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848406

Contacts

Contact: Maarten van den Berge, MD, PhD

+31-50-3615260

m.van.den.berge@int.umcg.nl

Locations

Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9713GZ

Sponsors and Collaborators

University Medical Centre Groningen

Investigators

Principal Investigator:

Maarten van den Berge, MD, PhD

University Medical C enter Groningen

More Information

No publications provided

Responsible Party:	University Medical Centre Groningen ( Maarten van den Berge )
Study ID Numbers:	METc2009007
Study First Received:	February 19, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848406 History of Changes
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

Study placed in the following topic categories:

Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Healthy
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on August 30, 2009