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

NCT00262340 | Completed

• 1 other identifier: 05/Q0404/30
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Asthma

Keywords

Asthma; Pediatrics; Airway; Inflammation

Outcome Measures

Primary Outcomes (2)

• Number of exacerbations;

  1 year

• Number of symptom free days and bronchodilator use per week

  1 year

Secondary Outcomes (2)

• Doses of inhaled and oral corticosteroid used per year

  1 year

• Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation

  1 year

Study Arms (2)

1

EXPERIMENTAL

This arm will have treatment changed based on measures of inflammation

Other: Non invasive measurement of airway inflammation

2

ACTIVE COMPARATOR

Treatment will be changed on the basis of reported asthma symptoms

Other: Non invasive measurement of airway inflammation

Interventions

Non invasive measurement of airway inflammation OTHER

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

1; 2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Heart and Lung Institute: collaborator
• Imperial College London: collaborator
• British Lung Foundation: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Bush, MBBS

  Imperial College of Science Technology and Medicine, National Heart and Lung Institue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

GB (1)