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Completed

NCT Number: NCT00848406

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. parameters for inflammation and remodelling in airway tissue

    Time frame: The duration of the study is estimated on 2 year

Secondary outcomes

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

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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

Acronym: NORM

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Feb 20, 2009
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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