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OpenTrials
Completed

NCT Number: NCT00849433

Effects of Smoking on Bronchial Epithelium

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.

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Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation 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–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. Epithelial integrity as measured with ECIS

    Time frame: 2 years

Secondary outcomes

  1. Inflammatory cells and mediators

    Time frame: 2 years

  2. Production of inflammatory cytokines

    Time frame: 2 years

  3. Markers of epithelial integrity

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Feb 23, 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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