The Pharmacokinetics of Systemic Corticosteriods in Refractory Asthma

Conditions: Severe, refractory asthma

Registration Number: EUCTR2004-001953-27-GB

Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Asthma cases:
1. Patients with refractory asthma (according to the American Thoracic Society Criteria for refractory asthma. Ref. American Journal of Respiratory and Critical Care Medicine 162(6):2341-2351)

Controls:
1.Healthy volunteers with no respiratory symptoms
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

Exclusion Criteria

1. Current smokers or ex-smokers with more than 10-pack year smoking history
2. Significant other co-morbidity, including hepatic, renal or endocrine dysfunction
3. Pregnant or breast feeding women
4. Concurrent oral medication likely to interfere with prednisolone pharmacokinetics, e.g. anti-convulsants
5. Concurrent oral prednisolone at a dose of more than 10mg per day

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether patients with severe asthma have abnormalities in the way that they absorb prednisolone tablets or clear them from the body compared to healthy controls.;Secondary Objective: To determine whether any differences in the absorption or clearing of prednisolone tablets relates to underlying airway inflammation in asthma, and whether patients with severe asthma have abnormal tissue responses to steriod treatment (by means of applying beclometasone dipropionate solution (not an IMP) topically. ;Primary end point(s): Assessment of the difference in pharmacokinetics of prednisolone between patients with refractory asthma, and healthy volunteers. <br><br>In addition, enteric-coated prednisolone tablets may reduce the systemic absorption of prednisolone in patients with refractory asthma.

Secondary Outcome Measures