Phase 4 Completed N=13 Diagnostic

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

Source: ClinicalTrials.gov NCT00283504 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcomePrimary: Number of Participants With Change in Sputum Markers by End of Study — 0; 0 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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)

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.