allergic asthma, airway smooth muscle, genomics, microarray, gene expression, Forced Oscillation Technique allergisch astma, luchtweg glad spierweefsel, gen expressie
Conditions
Interventions
During screening, patients will undergo a physical examination, skin prick test, spirometry, and methacholine bronchoprovocation test, and when applicable a urine pregnancy test. During the two study
Sponsors
Academic Medical Center Amsterdam
Contactperson:
P.J. Sterk
Dept. of Pulmonology (F5-259)
Academic Medical Center
University Hospital of Amsterdam
Meibergdreef 9
NL-1105AZ, Amsterdam, The Netherlands
Tel: 31-20-566 4356
Fax: 31-20-566 9001
Email: p.j.sterk@amc.uva.nl
Eligibility
Inclusion criteria
Inclusion criteria: Asthmatic patients: 1. Age between 18 – 50 years 2. History of episodic chest tightness and wheezing 3. Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma 4. Non-smoking or stopped smoking more than 12 months ago and 5 pack years or less 5. Clinically stable, no exacerbations within the last 6 weeks prior to the study 6. Occasional usage of inhaled short-acting ß2-agonists as rescue medication is allowed, prior and during the study 7. Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 8 weeks prior to the study 8. Baseline FEV1 ≥ 70% of predicted 9. Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20 ≤8 mg/ml 10. Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal ≥ 3mm in diameter 11. No other clinically significant abnormality on history and clinical examination Healthy patients: 1. Age between 18 – 50 years; 2. Non-smoking or stopped smoking more than 12 months and 5 pack years or less; 3. Baseline FEV1 ≥ 70% of predicted; 4. Negative methacholine challenge or PC20 >8 mg/ml; 5. Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 8 weeks prior to the study; 6. Negative history of pulmonary and any other relevant diseases. Additionally, non-asthmatic non-allergic patients must have a negative skin prick test (SPT) to one of the 12 common aeroallergen extracts, whereas non-asthmatic allergic patients must have a positive SPT.
Exclusion criteria
Exclusion criteria: Both groups of patients: 1. History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness 2. Women who are pregnant or lactating or who have a positive urine pregnancy test at screening 3. Chronic use of any other medication for treatment of lung disease other than short-acting ß2-agonists 4. Participation in any clinical investigational drug treatment protocol within the preceding 30 days 5. Ongoing use of tobacco products of any kind or previous usage with a total pack year ≥ 6 6. Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study 7. Unwillingness or inability to comply with the study protocol for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A genomic analysis of the airway smooth muscle layer of asthmatics and healthy, non-asthmatics by using laser capture microdissection (LCM) technique. | — |
Secondary
| Measure | Time frame |
|---|---|
| The profiles of ASM will be associated with physiologic parameters obtained by lung function tests, eNO, and FOT. The profiles of ASM will be associated with biochemical parameters obtained by immunohistochemistry. The presence and type of bronchial pathogens will be associated with clinical severity, and with the degree and profile of airways inflammation, airway remodelling and airway hyperresponsiveness by viral real-time multiplex PCR and bacterial PCR analysis. | — |
Contacts
Public ContactC.Y. Yick
Dept. of Pulmonology (F5-260) Academic Medical Center University Hospital of Amsterdam
Outcome results
None listed