Phase 4
N=5
Prednisolone Pharmacokinetics in Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00662298 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Serum Prednisolone Levels Over 24 Hours — 800; 700; NA nmol/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- prednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Prednisolone Levels Over 24 Hours |
800; 700; NA | — |
| PRIMARY Change in FEV1 24 Hours Post Prednisolone |
— | — |
| PRIMARY Changes in eNO, Sputum Eosinophils and Inflammatory Mediators Over 24 Hours |
— | — |
| SECONDARY Difference Between Baseline and Day 14 in Serum Prednisolone Levels |
2.0; 2.11 | — |
| SECONDARY Difference in FEV1 Between Day 1 and Day 14 |
— | — |
| SECONDARY Difference in Inflammatory Markers Between Day 1 and Day 14 |
— | — |
| SECONDARY Changes in Asthma Control Symptoms Before and After Treatment |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00662298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.