Phase 4
N=13
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
ALLERGIC ASTHMA
Bottom Line
View on ClinicalTrials.gov: NCT00283504 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Change in Sputum Markers by End of Study — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ANTI-IGE THERAPY (XOLAIR) (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of The King's Daughters
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Change in Sputum Markers by End of Study |
0; 0 | — |
| SECONDARY Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control |
7; 6 | — |
| SECONDARY Number Participants for Whom Sputum Induction Was Safe |
7; 6 | — |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00283504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.