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

NCT00848406 | Completed

• 1 other identifier: METc2009007
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Copd

Keywords

bronchial; COPD; Asthma; sputum; biopsies

Outcome Measures

Primary Outcomes (1)

• parameters for inflammation and remodelling in airway tissue

  The duration of the study is estimated on 2 year

Secondary Outcomes (1)

• Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.

  2 year

Study Arms (4)

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals

You may qualify if:

• Have not smoked during the last year.
• Have never smoked for as long as a year.
• Have \< 0.5 packyear.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 33320729 DERIVED

• 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.

  PMID: 33060632 DERIVED

• 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.

  PMID: 29268739 DERIVED

• 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.

  PMID: 28143620 DERIVED

• 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.

  PMID: 27117828 DERIVED

• 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.

  PMID: 25034386 DERIVED

• 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.

  PMID: 24622644 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maarten van den Berge, MD, PhD

  University Medical C enter Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

NL (1)