CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5 enrolled
Drug / intervention
prednisolonedrug
Likely dose
prednisolone 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00662298
NCT00662298Phase 4Completed

The Pharmacokinetics and Anti-inflammatory Effects of Prednisolone in Severe Asthma

Imperial College London·interventional·Posted Apr 21, 2008·Updated Nov 20, 2019

In Brief

A Phase 4 clinical trial evaluating prednisolone for Asthma. Completed, enrolled 5 participants across 1 site.

Detailed 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 the study are 1. to compare the effect of high dose prednisolone on clinical and physiological responses 2. to determine the effect of long-term oral prednisolone therapy on corticosteroid responsiveness and prednisolone pharmacokinetics 3. to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR translocation and activation of NF-kB 4. to validate an easier method of measuring corticosteroid insensitivity using whole blood, and a spot prednisolone serum level as a measure of adherence to prednisolone therapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2008
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.2 years ago

Interventions

prednisolonedrug

40mg of prednisolone once a day for 14 days