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Inflammation and Corticosteroid Responsiveness in Severe Asthma

This study is currently recruiting participants.
Verified by Imperial College London, May 2008

Sponsors and Collaborators: Imperial College London
National Institutes of Health (NIH)
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00180661
  Purpose

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   

Drug Information available for:   Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Corticosteroids   

U.S. FDA Resources

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

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Lung function FEV1 [ Time Frame: days ] [ Designated as safety issue: Yes ]
  • Suppression of monocyte activation and alveolar macrophage activation by dexamethasone ex-vivo [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Effect of corticosteroids on release of cytokines from macrophages [ Time Frame: Once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled NO [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Biopsy eosinophils [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Sputum eosinophils [ Time Frame: Once ] [ Designated as safety issue: No ]

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
Drug: Prednisolone
40 mg per day for 2 weeks

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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:

  1. Post-bronchodilator FEV1 greater than 40% on the day of the bronchoscopy
  2. No evidence of an exacerbation of asthma within the past 4 weeks.
  3. Ability to cooperate with procedures
  4. Ability to give consent
  5. Current smokers, and ex-smokers with greater than 10 pack years history of smoking.

Exclusion criteria

Pregnancy or unreliable contraceptive measures in child-bearing woman. he bronchoscopist has determined the subject is clinically appropriate for bronchoscopy

-

Exclusion Criteria:

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180661

Contacts
Contact: Fan Chung, MD     44 2073528121    

Locations
United Kingdom
Royal Brompton Hospital     Recruiting
      London, United Kingdom, SW3 6HP
      Contact: Sally Meah     44 207 351 8051        

Sponsors and Collaborators
Imperial College London
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Kian Fan Chung, MD     Imperial College London    
  More Information


Publications:

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

Keywords provided by Imperial College London:
Severe asthma  
corticosteroid responsiveness  

Study placed in the following topic categories:
Methylprednisolone
Asthma
Methylprednisolone acetate
Prednisolone acetate
Inflammation
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Prednisolone
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Antineoplastic Agents, Hormonal
Immune System Diseases
Bronchial Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 27, 2008




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