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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maarten van den Berge, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00848406
First received: February 19, 2009
Last updated: March 6, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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         
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 by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on October 02, 2014