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Effects of smoking and oxidative stress on airway remodeling and phenotypic changes of the airway epithelium in asthma and COPD: strategies to restore the epithelial barrier, repair and steroid sensitivity

Completed
Conditions
Asthma
COPD
emphysema
10006436
Registration Number
NL-OMON33504
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
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).

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- changes in epithelial integrity as measured with electrical cell impedance<br /><br>(ECIS) (during various conditions, i.e. with and without exposure to oxidative<br /><br>stress, with and without treatment with corticosteroids, with and without<br /><br>treatment with acetylcysteine, theophylline, heme oxygenase, carbon monoxide).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- production of pro-inflammatory cytokines during various conditions.<br /><br>- markers of epithelial integrity (e.g. E-cadherin, caveolin-1) during various<br /><br>conditions.<br /><br>- In biopsies the macroscopic quality of the bronchial epithelium will be<br /><br>assessed. In addition, we will investigate the expression of E-cadherin,<br /><br>caveolin-1 and heme-oxygenase.</p><br>
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