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

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Asthma; Copd

Study type: Observational

Funder types: Other

Identifiers

NCT00848406

METc2009007

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 4 patient groups

1

Description:

30 individuals ≤ 40 years, who currently smoke ≥ 10 cigarettes/day and \> 10 packyears

2

Description:

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

Description:

30 individuals above 40 years, who currently smoke ≥ 10 cigarettes per day, and \> 20 packyears.

4

Description:

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.