Effects of Smoking on Bronchial Epithelium

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Medical Centre Groningen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00849433
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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
Asthma
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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.

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Epithelial integrity as measured with ECIS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Inflammatory cells and mediators [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Production of inflammatory cytokines [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Markers of epithelial integrity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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
1
30 patients with asthma
2
30 patients with COPD

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 patients with asthma; 30 patients with COPD

Criteria

Inclusion Criteria:

Inclusion criteria for patients with allergic asthma:

  • Age between 18 and 65 years.
  • < 10 packyears, no smoking in the last year.
  • The presence of allergy defined as at least one positive wheal/flare reaction (2 mm relative to control) to a skin prick test with sixteen common aero-allergens).
  • FEV1 > 80% predicted.
  • PC20 methacholine or PC20 histamine < 8 mg/ml.

Inclusion criteria for patients with COPD:

  • Age between 45-75 years.
  • ≥ 10 packyears.
  • FEV1 between 30% and 80% of predicted.

Exclusion criteria:

  • Any disease that, as judged by the Investigator, could have affected the outcome of this study.
  • A respiratory tract infection within 4 weeks of the start of the study.
  • A history of life-threatening asthma, defined as exacerbation of asthma or COPD that required intubation or was associated with hypercapnea.
  • History of myocardial infarction or documented myocardial ischemia.
  • Pregnancy, or the possibility of being pregnant (a pregnancy test will be performed in women of childbearing potential who do not use adequate anticonception as judged by the investigator).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849433

Contacts
Contact: Maarten van den Berge, MD, PhD +31-50-3615260 m.van.den.berge@int.umcg.nl

Locations
Netherlands
University Medical Centre Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Contact: Maarten van den Berge, MD, PhD    +31-50-3616161    m.van.den.berge@int.umcg.nl   
Principal Investigator: Maarten van den Berge, MD. PhD         
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Maarten van den Berge, MD, PhD University Medical Centre Groningen
Study Director: Dirkje S Postma, Professor University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Maarten van den Berge, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00849433     History of Changes
Other Study ID Numbers: METc2009008
Study First Received: February 20, 2009
Last Updated: February 20, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Dutch Health Care Inspectorate

Keywords provided by University Medical Centre Groningen:
Inflammation
epithelial
integrity
ECIS

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014