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

Asthma Clinical Trial

— NORM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848406
• Other study ID #: METc2009007
• Status: Completed
• Phase: N/A
• First received: February 19, 2009
• Last updated: January 15, 2015
• Start date: April 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Netherlands: Dutch Health Care InspectorateNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Copd

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parameters for inflammation and remodelling in airway tissue		The duration of the study is estimated on 2 year	Yes
Secondary	Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.		2 year	No