The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Heart and Lung Institute
Imperial College London
British Lung Foundation
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00262340
First received: December 5, 2005
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to determine whether using non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelines)


Condition Intervention
Asthma
Other: Non invasive measurement of airway inflammation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Prospective, Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Number of exacerbations; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of symptom free days and bronchodilator use per week [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Doses of inhaled and oral corticosteroid used per year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2005
Estimated Study Completion Date: February 2008
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This arm will have treatment changed based on measures of inflammation
Other: Non invasive measurement of airway inflammation
Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management
Active Comparator: 2
Treatment will be changed on the basis of reported asthma symptoms
Other: Non invasive measurement of airway inflammation
Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management

Detailed Description:

Children with severe asthma pose a management dilemma; it is difficult to reduce their treatment while they are symptomatic, but the plateau of the dose response curve for inhaled corticosteroids (ICS) may have been reached. Studies in symptomatic adults and asymptomatic children with asthma suggest measuring induced sputum eosinophils allows better asthma management. We will recruit 80 children with severe asthma (treated with at least 500 mcg/day inhaled fluticasone or equivalent). We will see them every three months for a year, and perform sputum induction and measurements of exhaled nitric oxide (eNO). Half will be randomised to conventional management; half will have a reduction of ICS if there are no sputum eosinophils, or (if a sample cannot be produced) eNO is normal. The trial endpoint is whether there is a significant reduction in the median dose of ICS in the inflammatory markers group, with no increase in total number of asthma exacerbations. This study is also hypothesis generating. We will use our panel of markers (a) to try to improve clinical monitoring; and (b) to determine the molecular mechanisms of relapse of severe asthma.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children >8 years with severe asthma defined as:

Taking at least 500mcg fluticasone propionate (or equivalent) per day, plus a long acting beta agonist plus a leukotriene antagonist or previous trial

Exclusion Criteria:

Children taking steroid sparing agent (cyclosporin, azathioprine, methotrexate) Children with other major respiratory diagnoses such as bronchiectasis

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262340

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
National Heart and Lung Institute
Imperial College London
British Lung Foundation
Investigators
Principal Investigator: Andrew Bush, MBBS Imperial College of Science Technology and Medicine, National Heart and Lung Institue
  More Information

No publications provided

Responsible Party: Professor Andrew Bush, Imperial college London
ClinicalTrials.gov Identifier: NCT00262340     History of Changes
Other Study ID Numbers: 05/Q0404/30
Study First Received: December 5, 2005
Last Updated: February 12, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Asthma
Pediatrics
Airway
Inflammation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014