Status:
COMPLETED
Airway Smooth Muscle and Asthma Severity
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Asthma UK
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Brief Summary
Our hypothesis is that the severity of asthma is determined by the way in which airway smooth muscle cells grow and release inflammatory mediators. Our main objective is to establish how the propertie...
Detailed Description
Aims and Objectives The objective of this study is to examine whether the severity of asthma is related to (and possibly caused by) ASM dysfunction. Severe asthmatics have been shown to have more ASM ...
Eligibility Criteria
Inclusion
- Inclusion criteria - Asthma Age 18-60 Physician diagnosis of asthma Intermittent/mild, moderate and severe asthma as per GINA guidelines \[1\]
- For the severe asthma subjects, they will also have the following:
- Major characteristics (at least one of the following criteria)
- Treatment with continuous or near continuous (\>50% of year) oral corticosteroids
- Requirement for treatment with high dose inhaled corticosteroids (ICS) Minor characteristics (at least 2 out of the following)
- Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist
- Asthma symptoms requiring SABA on a daily or near daily basis
- Persistent airways obstruction (FEV1 \<80% predicted, diurnal PEF variation \>20%)
- One or more emergency care visits for asthma per year
- 3 or more steroid "bursts" per year
- Prompt deterioration with ≤ 25% reduction in oral or ICS
- Near fatal asthma event in the past
- Reference \[1\] GINA - The Global Initiative for Asthma. www.ginasthma.com
- Exclusion criteria - Asthma Intubation for asthma within 6 months of entry into this study Current smokers, or less than 3 years since quitting smoking (\< 5 pack/years) Less than 4 weeks from an exacerbation On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin Concomitant anti-IgE therapy On anti-platelet or anti-coagulant drugs Low platelet count Pregnancy or breast-feeding Previous bronchoscopy within three months of this study
- Healthy volunteer subjects:
- We are aiming for 5 atopic and 5 non-atopic healthy volunteers.
- Inclusion criteria:
- Age 18 - 60 Non smokers (or less than 5 pack/yrs if ex-smokers) Normal lung function
- Exclusion criteria:
- History of asthma or allergic rhinitis Any chronic illness Current smokers, or less than 3 years since quitting smoking (\< 5 pack/years) PC20 less than 16mg/ml On anti-platelet or anti-coagulant drugs Low platelet count Pregnancy or breast-feeding Previous bronchoscopy within three months of this study
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00779870
Start Date
October 1 2008
End Date
September 1 2012
Last Update
October 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Brompton Hospital
London, United Kingdom, Sw3 6NP