The pharmacokinetics and anti-inflammatory effects of prednisolone in severe asthma. - Prednisolone in severe asthma
- Conditions
- This study is designed to look why patients with severe asthma fail to respond to oral corticosteroids in the same way as patients with non-severe disease.MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2007-002084-27-GB
- Lead Sponsor
- Imperial College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Severe asthma subjects:
Physician diagnosis of asthma
Aged 18 – 70
Non-smokers or ex-smokers with less than 5 pack/year history
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)
1.Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist
2.Asthma symptoms requiring SABA on a daily or near daily basis
3.Persistent airways obstruction (FEV1 <80% predicted, diurnal PEF variation >20%)
4.One or more emergency care visits for asthma per year
5.3 or more steroid bursts” per year
6.Prompt deterioration with = 25% reduction in oral or ICS
7.Near fatal asthma event in the past
Moderately-severe asthma:
Physician diagnosis of asthma
Aged 18 – 70
Non-smokers or ex-smokers with less than 5 pack/year history
Less than 2 courses of prednisolone per year
Taking up to 2000 mcg of inhaled corticosteroid (BDP equivalent) per day
Stable asthma for at least 6 months prior to enrolment
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) yes
F.1.3.1 Number of subjects for this age range
Current smokers, or less than 3 years since quitting smoking
Less than 4 weeks from an exacerbation
Diabetes
Active peptic ulceration
Previous history of psychiatric disturbances on high dose prednisolone
On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
Concomitant anti-IgE therapy
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method