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

• ClinicalTrials.gov Identifier: NCT00848406
• Recruitment Status: Completed
• First Posted: February 20, 2009
• Last Update Posted: January 16, 2015
• Sponsor: University Medical Center Groningen
• Information provided by (Responsible Party): Maarten van den Berge, University Medical Center Groningen

Tracking Information

• First Submitted Date: February 19, 2009
• First Posted Date: February 20, 2009
• Last Update Posted Date: January 16, 2015
• Study Start Date: April 2009
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 19, 2009): parameters for inflammation and remodelling in airway tissue [ Time Frame: The duration of the study is estimated on 2 year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 19, 2009): Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan. [ Time Frame: 2 year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects
• 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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

• Sampling Method: Probability Sample
• Study Population: Healthy individuals

Condition

• Asthma
• Copd

• Intervention: Not Provided

Study 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.

Publications *

• Nair GB, Galban CJ, Al-Katib S, Podolsky R, van den Berge M, Stevens C, Castillo E. An assessment of the correlation between robust CT-derived ventilation and pulmonary function test in a cohort with no respiratory symptoms. Br J Radiol. 2021 Feb 1;94(1118):20201218. doi: 10.1259/bjr.20201218. Epub 2020 Dec 15.
• Faiz A, Imkamp K, van der Wiel E, Boudewijn IM, Koppelman GH, Brandsma CA, Kerstjens HAM, Timens W, Vroegop S, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Steiling K, Spira A, Lenburg ME, Heijink IH, Postma DS, van den Berge M. Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD. Sci Rep. 2020 Oct 15;10(1):17415. doi: 10.1038/s41598-020-72551-0.
• Boudewijn IM, Faiz A, Steiling K, van der Wiel E, Telenga ED, Hoonhorst SJM, Ten Hacken NHT, Brandsma CA, Kerstjens HAM, Timens W, Heijink IH, Jonker MR, de Bruin HG, Sebastiaan Vroegop J, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Spira A, Lenburg ME, Guryev V, Postma DS, van den Berge M. Nasal gene expression differentiates COPD from controls and overlaps bronchial gene expression. Respir Res. 2017 Dec 21;18(1):213. doi: 10.1186/s12931-017-0696-5.
• Telenga ED, Oudkerk M, van Ooijen PM, Vliegenthart R, Ten Hacken NH, Postma DS, van den Berge M. Airway wall thickness on HRCT scans decreases with age and increases with smoking. BMC Pulm Med. 2017 Feb 1;17(1):27. doi: 10.1186/s12890-017-0363-0.
• Hoonhorst SJ, Lo Tam Loi AT, Pouwels SD, Faiz A, Telenga ED, van den Berge M, Koenderman L, Lammers JW, Boezen HM, van Oosterhout AJ, Lodewijk ME, Timens W, Postma DS, Ten Hacken NH. Advanced glycation endproducts and their receptor in different body compartments in COPD. Respir Res. 2016 Apr 26;17:46. doi: 10.1186/s12931-016-0363-2.
• Hoonhorst SJ, Lo Tam Loi AT, Hartman JE, Telenga ED, van den Berge M, Koenderman L, Lammers JW, Boezen HM, Postma DS, Ten Hacken NH. Advanced glycation end products in the skin are enhanced in COPD. Metabolism. 2014 Sep;63(9):1149-56. doi: 10.1016/j.metabol.2014.06.006. Epub 2014 Jun 13.
• Hoonhorst SJ, ten Hacken NH, Lo Tam Loi AT, Koenderman L, Lammers JW, Telenga ED, Boezen HM, van den Berge M, Postma DS. Lower corticosteroid skin blanching response is associated with severe COPD. PLoS One. 2014 Mar 12;9(3):e91788. doi: 10.1371/journal.pone.0091788. eCollection 2014.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 19, 2009): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00848406
• Other Study ID Numbers: METc2009007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Maarten van den Berge, University Medical Center Groningen
• Original Responsible Party: Maarten van den Berge, University Medical Centre Groningen
• Current Study Sponsor: University Medical Center Groningen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Maarten van den Berge, MD, PhD; University Medical C enter Groningen

• PRS Account: University Medical Center Groningen
• Verification Date: January 2015