AsthmaNORMNCT00848406
A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects
An observational study of Asthma and Copd, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2009to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals
Who may be able to join
- Have not smoked during the last year.
- Have never smoked for as long as a year.
- Have < 0.5 packyear.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
About this study
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
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.
- Keywords
- bronchial, COPD, Asthma, sputum, biopsies
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
parameters for inflammation and remodelling in airway tissue
Measured: The duration of the study is estimated on 2 year
Secondary outcomes (1)
Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Maarten van den Berge, MD, PhD, Principal investigator, University Medical C enter Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848406
- Sponsor's protocol ID
- METc2009007
- Acronym
- NORM
- Status last verified
- Jan 2015
- First submitted
- 19 Feb 2009
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33320729Faiz 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.
PubMed 33060632Boudewijn 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.
PubMed 29268739Telenga 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.
PubMed 28143620Hoonhorst 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.
PubMed 27117828Hoonhorst 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.
PubMed 25034386Hoonhorst 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.
PubMed 24622644
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00848406
- Acronym / sponsor ID
- NORM / METc2009007
- Keywords
- bronchial, COPD, Asthma, sputum, biopsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals
Key inclusion criteria (3 listed)
- Have not smoked during the last year.
- Have never smoked for as long as a year.
- Have < 0.5 packyear.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
parameters for inflammation and remodelling in airway tissue
Time frame: The duration of the study is estimated on 2 year
1 secondary outcome
Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Derived from this study: PubMed 33320729Nair 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.
- Derived from this study: PubMed 33060632Faiz 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.
- Derived from this study: PubMed 29268739Boudewijn 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.
- Derived from this study: PubMed 28143620Telenga 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.
- Derived from this study: PubMed 27117828Hoonhorst 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.
- Derived from this study: PubMed 25034386Hoonhorst 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.
- Derived from this study: PubMed 24622644Hoonhorst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten van den Berge, MD, PhD principal investigator
University Medical C enter Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Copd, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters for inflammation and remodelling in airway tissue (time frame: The duration of the study is estimated on 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848406, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.