Status:
COMPLETED
Effects of Smoking on Bronchial Epithelium
Lead Sponsor:
University Medical Center Groningen
Conditions:
Asthma
Copd
Eligibility:
All Genders
18-75 years
Brief Summary
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 tre...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00849433
Start Date
April 1 2009
End Date
April 1 2013
Last Update
January 16 2015
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ