The effect of inhaled corticosteroids (ICS) on airway smooth muscle in asthma - ICS and ASM in asthma

Conditions: Asthma is a disease characterised by reversible airways obstruction, bronchial hyper-responsiveness (BHR), and chronic inflammation of the bronchial mucosal lining. Structural changes in the airway wall, collectively known as airway wall remodelling, include, subbasement membrane thickening, smooth muscle hyperplasia/hypertrophy, and collagen deposition. These changes may be responsible for an increased decline in lung function, irreversible airflow obstruction and BHR seen in chronic asthma.
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2007-006664-29-GB

Lead Sponsor: Imperial College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

Physician diagnosis of asthma
Age 18-60
Intermittent asthma symptoms < once/week
FEV1>80% of predicted
Not on inhaled corticosteroid therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous long-term use of inhaled corticosteroids (within 1 year of entry into study)
Past History of hypersensitivity to budesonide
Current smokers, or less than 3 years since quitting smoking
Less than 4 weeks from an exacerbation
On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
Concomitant anti-IgE therapy
Pregnancy
Previous bronchoscopy within three months of this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to evaluate how treatment with inhaled corticosteroids affects the characteristics of airway smooth muscle cells. 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.;Secondary Objective: ;Primary end point(s): Primary endpoints:<br>1. Changes in airway smooth muscle (ASM) mass, proliferation and migration after inhaled corticosteroid therapy <br>2. Changes in chemokine release after inhaled corticosteroid therapy<br><br>Secondary endpoints: <br>1. Changes in sub-basement membrane thickness and inflammatory cell count after inhaled corticosteroid therapy<br>2. Correlation between ASM mass and airway hyper-responsiveness<br><br><br>

Secondary Outcome Measures