Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Imperial College London Royal Brompton Hospital NHS Trust |
---|---|
Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00661973 |
The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our hypothesis is that airway smooth muscle cell dysfunction plays an important role in the pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the abnormalities in airway smooth muscle cell function.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: budesonide |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | The Effect of Inhaled Corticosteroids (ICS) on Airway Smooth Muscle in Asthma |
Estimated Enrollment: | 12 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Aims and Objectives
Most of the work published to date on the effect of steroids on ASM has been carried out in animal models or in in vitro experiments. We would like to evaluate in vivo whether abnormalities in ASM function respond to ICS. Because ASM cells can be obtained from bronchial biopsies obtained via bronchoscopy, we will examine endobronchial biopsies from corticosteroid-naïve, mild asthmatic subjects. In particular, we will examine whether ICS have any effect ASM mass, proliferation and expression of different contractile proteins (α-actin and myosin) and chemokines, and will assess in vitro the response of ASM cells to stimulation by TGF-β and IL-1β. We will also examine the effect of dexamethasone on chemokine release and induced proliferation in vitro before and after treatment with ICS.
We will examine the effect of inhaled corticosteroids in 12 subjects with mild asthma. The subjects will be studied during a baseline period and again after receiving treatment with inhaled corticosteroid therapy with Budesonide Turbohaler (400 ug bd) for 4 weeks. The results of these two periods will be compared.
There will be 5 study visits. In the first two visits, the subjects will undergo spirometry with reversibility testing, a methacholine challenge test, skin prick tests and IgE levels, measurement of exhaled nitric oxide, and subjects will complete an Asthma Control Questionnaire and an Asthma Quality of Life Questionnaire. The third visit will be the day admission for the bronchoscopy. They will be given asthma control diary cards to complete during the 4-week treatment with ICS and receive their ICS turbohaler. At visit 4, they will have repeat spirometry and methacholine challenge to assess if there has been a change secondary to treatment with ICS. The final visit will be for the second bronchoscopy, when the dairy card and ICS inhaler will be collected, and the subjects will complete the Asthma Control and Quality of Life questionnaire.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kian F Chung, MBBS FRCP MD DSc | 02-07-351-8995 | f.chung@imperial.ac.uk |
Contact: Patricia Macedo, MBBS MRCP MSc | 02-07-351-8051 | p.macedo@imperial.ac.uk |
United Kingdom | |
Asthma lab, Royal Brompton Hospital, Sydney Street | |
London, United Kingdom, SW3 6NP |
Principal Investigator: | Kian F Chung, MBBS FRCP MD DSc | Imperial College London |
Responsible Party: | Imperial College London ( Professor Kian Fan Chung ) |
Study ID Numbers: | 2007-006664-29, 07/H0803/239 |
Study First Received: | April 16, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00661973 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
asthma airway smooth muscle inhaled corticosteroids |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Budesonide Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |