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Sponsored by: |
University Medical Centre Groningen |
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Information provided by: | University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00849433 |
Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory airway diseases affecting millions of people worldwide. Inhaled corticosteroids (ICS) are by far the most effective treatment with a broad anti-inflammatory spectrum. Nevertheless, most COPD patients and a proportion of severe asthma patients are corticosteroid-resistant (CR) and to fail to respond to ICS even when higher doses are given. These corticosteroid-resistant patients suffer from persistent symptoms and repeated asthma exacerbations. It has been suggested that smoking and oxidative stress may induce corticosteroid-resistance. The reactive oxygen species (ROS) responsible for oxidative stress can be generated exogenously (air pollutants, cigarette smoke) and endogenously by metabolic reactions. After inhaling air pollutants or cigarette smoke, the bronchial epithelium is exposed. Preliminary data from our own lab suggest that smoking and oxidative stress may decrease epithelial cell-cell contact formation. This results not only in a decreased barrier function, but also in an increased production of pro-inflammatory mediators.
Condition |
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Asthma COPD |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effects of Smoking on Airway Remodeling and Phenotypic Changes of the Airway Epithelium in Asthma and COPD: Strategies to Restore the Epithelial Barrier, Repair and Steroid Sensitivity. |
Bronchial biopsies Bronchial brushes Blood
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
30 patients with asthma
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2
30 patients with COPD
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
30 patients with asthma; 30 patients with COPD
Inclusion Criteria:
Inclusion criteria for patients with allergic asthma:
Inclusion criteria for patients with COPD:
Exclusion criteria:
Contact: Maarten van den Berge, MD, PhD | +31-50-3615260 | m.van.den.berge@int.umcg.nl |
Netherlands | |
University Medical Centre Groningen | |
Groningen, Netherlands, 9713 GZ |
Principal Investigator: | Maarten van den Berge, MD, PhD | University Medical Centre Groningen |
Study Director: | Dirkje S Postma, Professor | University Medical Centre Groningen |
Responsible Party: | University Medical Centre Groningen ( Maarten van den Berge ) |
Study ID Numbers: | METc2009008 |
Study First Received: | February 20, 2009 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00849433 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: Dutch Health Care Inspectorate |
Inflammation epithelial integrity ECIS |
Smoking Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |