The Pharmacokinetics of Systemic Corticosteriods in Refractory Asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001953-27-GB

Enrollment

Registered

2005-02-15

Start date

2004-12-13

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe, refractory asthma

Interventions

Trade Name: Prednisolone tablets BP Product Name: Prednisolone Pharmaceutical Form: Tablet Trade Name: Deltacortril Enteric Product Name: Deltacortril Enteric Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. In addition, enteric-coated prednisolone tablets may reduce the systemic absorption of prednisolone in patients with refractory asthma.	—

Measure

Time frame

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. In addition, enteric-coated prednisolone tablets may reduce the systemic absorption of prednisolone in patients with refractory asthma.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026