Inflammation and Corticosteroid Responsiveness in Severe Asthma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Imperial College London. Recruitment status was Recruiting

First Received on September 12, 2005. Last Updated on May 19, 2008 History of Changes

Sponsor:	Imperial College London
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Inflammation and Corticosteroid Responsiveness in Severe Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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
Experimental: A Treatment with prednisolone	Drug: Prednisolone 40 mg per day for 2 weeks

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:

Post-bronchodilator FEV1 greater than 40% on the day of the bronchoscopy
No evidence of an exacerbation of asthma within the past 4 weeks.
Ability to cooperate with procedures
Ability to give consent
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:

Chung KF, Godard P, Adelroth E, Ayres J, Barnes N, Barnes P, Bel E, Burney P, Chanez P, Connett G, Corrigan C, de Blic J, Fabbri L, Holgate ST, Ind P, Joos G, Kerstjens H, Leuenberger P, Lofdahl CG, McKenzie S, Magnussen H, Postma D, Saetta M, Salmeron S, Sterk P. Difficult/therapy-resistant asthma: the need for an integrated approach to define clinical phenotypes, evaluate risk factors, understand pathophysiology and find novel therapies. ERS Task Force on Difficult/Therapy-Resistant Asthma. European Respiratory Society. Eur Respir J. 1999 May;13(5):1198-208. Review. No abstract available.

Responsible Party:	Kian Fan Chung, Imperial College
ClinicalTrials.gov Identifier:	NCT00180661 History of Changes
Other Study ID Numbers:	HL-69155
Study First Received:	September 12, 2005
Last Updated:	May 19, 2008
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Severe asthma
corticosteroid responsiveness

Additional relevant MeSH terms:

Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone

Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
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

ClinicalTrials.gov processed this record on February 09, 2012