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Rhinovirus type 16-induced exacerbation in asthma.

The airway smooth muscle cell in asthma: Rhinovirus 16 infection.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26994
Enrollment
24
Registered
2010-06-22
Start date
2011-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic asthma/allergisch astma, Airway Smooth Muscle (ASM)/ luchtweg glad spierweefsel, gene expression analysis/genexpressie analyse, RNA whole transcriptome sequencing

Interventions

Spirometry, bronchoprovocation with methacholine, allergy skin prick test, measurement of respiratory impedance using Forced Oscillation Technique, eNO measurement, bronchoscopy with brushes and biops

Sponsors

Academic Medical Center (AMC) Dept. of Respiratory Medicine 1105AZ Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Asthmatic patients will be selected using the following inclusion criteria: 1. Age between 18 – 50 years; 2. History of episodic chest tightness and wheezing; 3. Controlled asthma according to the criteria by the Global Initiative for Asthma; 4. Non-smoking or stopped smoking > 12 months ago and ≤ 5 pack years; 5. Clinically stable, no exacerbations within the last 6 weeks prior to the study; 6. 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. Occasional usage of inhaled short-acting Beta2-agonists as rescue medication is allowed, prior and during the study; 7. Baseline FEV1 > 70% of predicted; 8. Airway hyperresponsiveness, indicated by a positive acetyl-ß-methylcholine bromide (MeBr) challenge with PC20 3mm. Control-group, non-asthmatic subjects are recruited using the following inclusion criteria: 1. Age between 18 – 50 years; 2. Non-smoking or stopped smoking > 12 months and ≤ 5 pack years; 3. Baseline FEV1 > 70% of predicted; 4. Acetyl-ß-methylcholine bromide challenge with PC20 > 9.8 mg/ml; 5. Negative skin prick test to one or more of the 12 common aeroallergen extracts; 6. Steroid-naïve or those participants who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 8 weeks prior to the study; 7. Negative history of pulmonary or any other relevant diseases.

Exclusion criteria

Exclusion criteria: Exclusion criteria for both patient-groups are as follows: 1. Presence of antibodies directed against RV16 in serum, measured at visit 1; 2. History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness; 3. Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1; 4. Chronic use of any other medication for treatment of lung disease other than short-acting Beta2-agonists; 5. Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total pack years.

Design outcomes

Primary

MeasureTime frame
To investigate the consequences of an experimental, RV16-induced exacerbation on the gene expression profile of airway smooth muscle (ASM) using RNA whole transcriptome sequencing.

Secondary

MeasureTime frame
1. The gene expression profile of ASM will be associated with physiologic parameters obtained by lung function tests, FOT, and eNO, between study groups and between pre- and post-exposure to RV16; 2. The gene expression profile of ASM will be associated with morphometry and immunohistochemistry on sections of biopsy specimens, between study groups and between pre- and post-exposure to RV16; 3. The gene expression profile of bronchial epithelial cells will be investigated between study groups prior and after exposure to RV16.

Contacts

Public ContactC.Y. Yick

Dept. of Pulmonology (F5-260) Academic Medical Center University Hospital of Amsterdam

c.y.yick@amc.uva.nl+31 (0)20 5669111 / 566 4359

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)