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Sponsors and Collaborators: |
Imperial College London National Institutes of Health (NIH) |
Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00180661 |
Some patients with mild asthma may develop severe asthma. It is not known what makes patients with mild asthma become severe, and we plan to find out why this happens. Patients with severe asthma may have a different type of inflammation in the airway tubes. Patients with severe asthma do not get as much benefit from taking steroid inhalers or tablets compared to asthma patients with mild disease. The study hypothesis is that the inflammation in severe asthma is such that it makes steroids less effective in treating asthma. We will find out what possible abnormalities there are in the blood cells and the bronchoalveolar macrophage cells in the lungs of patients with severe asthma compared to those with mild or moderate asthma.
Condition | Intervention | Phase |
Asthma |
Drug: Prednisolone |
Phase II Phase III |
MedlinePlus related topics: | Asthma |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Inflammation and Corticosteroid Responsiveness in Severe Asthma |
Estimated Enrollment: | 20 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Treatment with prednisolone
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Drug: Prednisolone
40 mg per day for 2 weeks
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The final diagnosis of severe asthma will be made according to the screening steps we have set up. The definition will require the presence of one or both major criteria (treatment with continuous or near continuous oral corticosteroids and/or requirement for treatment with high dose inhaled steroids) and two minor criteria.
Patients who do not fit the criteria of severe asthma will not be entered into the study.
Age 18-60; both sexes.
For the investigation of fiberoptic bronchoscopy, other additional inclusion criteria will be imposed:
Exclusion criteria
Pregnancy or unreliable contraceptive measures in child-bearing woman. he bronchoscopist has determined the subject is clinically appropriate for bronchoscopy
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Exclusion Criteria:
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Contact: Fan Chung, MD | 44 2073528121 |
United Kingdom | |||||
Royal Brompton Hospital | Recruiting | ||||
London, United Kingdom, SW3 6HP | |||||
Contact: Sally Meah 44 207 351 8051 |
Imperial College London |
National Institutes of Health (NIH) |
Principal Investigator: | Kian Fan Chung, MD | Imperial College London |
Responsible Party: | Imperial College ( Kian Fan Chung ) |
Study ID Numbers: | HL-69155 |
First Received: | September 12, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00180661 |
Health Authority: | United Kingdom: Research Ethics Committee |
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