Status:
COMPLETED
Prednisolone Pharmacokinetics in Severe Asthma
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate whether severe asthmatic subjects have abnormal prednisolone absorption, and how this might affect the anti-inflammatory effects of prednisolone. The aims of t...
Detailed Description
Asthma is a disease characterized by reversible airways obstruction, bronchial hyper-responsiveness, and chronic inflammation of the bronchial mucosal lining. Currently over 5 million people (6-8% of ...
Eligibility Criteria
Inclusion
- for severe asthmatics:
- 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)
- 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
- for 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 enrollment
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00662298
Start Date
June 1 2011
End Date
January 1 2013
Last Update
November 20 2019
Active Locations (1)
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1
Asthma Laboratory, Royal Brompton Hospital
London, United Kingdom, SW3 6LY