Prednisolone Pharmacokinetics in Severe Asthma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Imperial College London.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Imperial College London
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00662298
First received: April 14, 2008
Last updated: June 22, 2011
Last verified: June 2011
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Purpose
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
- to compare the effect of high dose prednisolone on clinical and physiological responses
- to determine the effect of long-term oral prednisolone therapy on corticosteroid responsiveness and prednisolone pharmacokinetics
- to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR translocation and activation of NF-kB
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: prednisolone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The Pharmacokinetics and Anti-inflammatory Effects of Prednisolone in Severe Asthma |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- serum prednisolone levels over 24 hours [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- change in FEV1 24 hours post prednisolone [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- changes in eNO, sputum eosinophils and inflammatory mediators over 24 hours [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- difference between day 1 and day 14 in serum prednisolone levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- difference in FEV1 between day 1 and day 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- difference in inflammatory markers between day 1 and day 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- changes in asthma control symptoms before and after treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: prednisolone
40mg of prednisolone once a day for 14 days
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 <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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662298
Contacts
| Contact: Patricia Macedo | 02-07-351-8051 | p.macedo@imperial.ac.uk |
| Contact: Florence Chow | 02-07-351-8051 | florence.chow@imperial.ac.uk |
Locations
| United Kingdom | |
| Asthma Laboratory, Royal Brompton Hospital | Recruiting |
| London, United Kingdom, SW3 6LY | |
| Sub-Investigator: Patricia Macedo, MBBS MRCP MSc | |
| Principal Investigator: Kian F Chung, MBBS MD FRCP DSc | |
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Investigators
| Principal Investigator: | Kian F Chung | Imperial College London |
More Information
No publications provided
| Responsible Party: | Professor Kian Fan Chung, Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00662298 History of Changes |
| Other Study ID Numbers: | 2007-002084-27, REC ref number 07/H0801/119 |
| Study First Received: | April 14, 2008 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
|
severe asthma prednisolone pharmacokinetics anti-inflammatory effects |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Methylprednisolone acetate Prednisolone acetate Anti-Inflammatory Agents Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate |
Prednisolone hemisuccinate Prednisolone phosphate Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 17, 2013