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Inflammation and Corticosteroid Responsiveness in Severe Asthma (SARP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180661
First Posted: September 16, 2005
Last Update Posted: October 29, 2015
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fan Chung, Imperial College London
  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 Phase
Asthma Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Inflammation and Corticosteroid Responsiveness in Severe Asthma

Resource links provided by NLM:


Further study details as provided by Fan Chung, Imperial College London:

Primary Outcome Measures:
  • Lung function FEV1 [ Time Frame: days ]
  • Suppression of monocyte activation and alveolar macrophage activation by dexamethasone ex-vivo [ Time Frame: Days ]
  • Effect of corticosteroids on release of cytokines from macrophages [ Time Frame: Once ]

Secondary Outcome Measures:
  • Exhaled NO [ Time Frame: Days ]
  • Biopsy eosinophils [ Time Frame: Once ]
  • Sputum eosinophils [ Time Frame: Once ]

Biospecimen Retention:   Samples With DNA
endobronchial biopsies and blood specimens.

Enrollment: 95
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe Asthma
Patients under Steps 4/5 of Asthma Treatment - SIGN/BTS Guidelines
Moderate Asthma
Asthma patients on steps 2/3 of Asthma treatment according to SIGN/BTS Guidelines
Mild Asthma
Asthma patients on steps 1 of asthma treatment (steroid naive).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Asthma population living in the UK - ranging in severity (from mild, to severe).
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
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 ClinicalTrials.gov identifier (NCT number): NCT00180661


Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6HP
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: Fan Chung, Professor, Imperial College London
ClinicalTrials.gov Identifier: NCT00180661     History of Changes
Other Study ID Numbers: HL-69155
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Fan Chung, 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