A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:

1. pulmonary function test (PFT)

2. asthma symptoms based on the Asthma Control Test (ACT)

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of The King's Daughters
• Collaborators: Genentech, Inc.; Novartis
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Moderate to severe allergic asthma, uncontrolled on conventional therapy

Exclusion Criteria:

• History of systemic illness, currently on other immune modulators like immunotherapy, IVIg

• Pregnancy

• IgE level >1300