Prednisolone Pharmacokinetics in Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662298
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : March 26, 2015
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Fan Chung, Imperial College London

Brief 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

Condition or disease Intervention/treatment Phase
Asthma Drug: prednisolone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Pharmacokinetics and Anti-inflammatory Effects of Prednisolone in Severe Asthma
Study Start Date : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Severe Asthma Drug: prednisolone
40mg of prednisolone once a day for 14 days

Primary Outcome Measures :
  1. serum prednisolone levels over 24 hours [ Time Frame: 14 days ]
  2. change in FEV1 24 hours post prednisolone [ Time Frame: 14 days ]
  3. changes in eNO, sputum eosinophils and inflammatory mediators over 24 hours [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. difference between day 1 and day 14 in serum prednisolone levels [ Time Frame: 14 days ]
  2. difference in FEV1 between day 1 and day 14 [ Time Frame: 14 days ]
  3. difference in inflammatory markers between day 1 and day 14 [ Time Frame: 14 days ]
  4. changes in asthma control symptoms before and after treatment [ Time Frame: 14 days ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

      1. Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist
      2. Asthma symptoms requiring SABA on a daily or near daily basis
      3. Persistent airways obstruction (FEV1 <80% predicted, diurnal PEF variation >20%)
      4. One or more emergency care visits for asthma per year
      5. 3 or more steroid "bursts" per year
      6. Prompt deterioration with ≤ 25% reduction in oral or ICS
      7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662298

United Kingdom
Asthma Laboratory, Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Kian F Chung Imperial College London

Responsible Party: Fan Chung, Professor, Imperial College London Identifier: NCT00662298     History of Changes
Other Study ID Numbers: 2007-002084-27
REC ref number 07/H0801/119
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: June 2011

Keywords provided by Fan Chung, Imperial College London:
severe asthma
prednisolone pharmacokinetics
anti-inflammatory effects

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents