Status:
COMPLETED
p38 Mitogen-Activated Protein Kinase (MAPK) and Steroid Insensitivity in Asthma
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Medical Research Council
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Brief Summary
This research aims to find out how the inflammation in patients suffering from severe asthma is different from that in non-severe asthma, and how it may prevent corticosteroids from working efficientl...
Detailed Description
DESIGN Comparative study to analyse differences in the characteristics of lung macrophages and blood monocytes between non-severe and severe asthmatics. AIMS 1. To determine whether there are differ...
Eligibility Criteria
Inclusion
- Age 18-60
- Physician diagnosis of asthma
- Non-severe asthmatic subjects:
- mild to moderately severe asthma.
- The groups will be defined as follows, according to their need for treatments (as established in the Asthma Management GINA or BTS guidelines):
- Mild: intermittent symptoms and need for reliever bronchodilator less than once a day
- moderate asthma: well-controlled asthma with minimal symptoms while on inhaled corticosteroid therapy not exceeding 2,000 μg beclomethasone equivalent.
- Severe asthmatic subjects:
- will have at least 1 major and 2 minor criteria (as below) 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
Exclusion
- 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
- Intubation for asthma within 6 months of entry into this study (if undergoing bronchoscopy)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00676572
Start Date
May 1 2008
End Date
October 1 2011
Last Update
October 15 2019
Active Locations (1)
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1
Asthma Laboratory, Royal Brompton Hospital, Sydney Street
London, United Kingdom, SW3 6NP