Effects of Smoking on Bronchial Epithelium

NCT ID: NCT00849433

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-04-30

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 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.

Conditions

Asthma; Copd

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

30 patients with asthma

No interventions assigned to this group

2

30 patients with COPD

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Maarten van den Berge

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarten van den Berge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Dirkje S Postma, Professor

Role: STUDY_DIRECTOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

METc2009008

Identifier Type: -

Identifier Source: org_study_id