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Sponsors and Collaborators: |
Imperial College London Royal Brompton Hospital NHS Trust |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00662298 |
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
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: prednisolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Pharmacokinetics and Anti-Inflammatory Effects of Prednisolone in Severe Asthma |
Estimated Enrollment: | 45 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
for severe asthmatics:
Minor characteristics (at least 2 out of the following)
for moderately-severe asthma:
Exclusion Criteria:
Contact: Patricia Macedo | 02-07-351-8051 | p.macedo@imperial.ac.uk |
Contact: Florence Chow | 02-07-351-8051 | florence.chow@imperial.ac.uk |
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 |
Principal Investigator: | Kian F Chung | Imperial College London |
Responsible Party: | Imperial College London ( Professor Kian Fan Chung ) |
Study ID Numbers: | 2007-002084-27, REC ref number 07/H0801/119 |
Study First Received: | April 14, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00662298 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
severe asthma prednisolone pharmacokinetics anti-inflammatory effects |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Bronchial Diseases Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Asthma Methylprednisolone acetate Prednisolone acetate Neuroprotective Agents |
Hormones Glucocorticoids Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Respiratory Hypersensitivity Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Bronchial Diseases Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Methylprednisolone Hemisuccinate |
Immune System Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Asthma Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Central Nervous System Agents Respiratory Hypersensitivity |