Trial Outcomes & Findings for A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (NCT NCT00283504)

NCT ID: NCT00283504

Last Updated: 2018-02-19

Results Overview

sputum markers were classified as eosinophilic or non eosinophilic

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

32 weeks

Results posted on

2018-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Eosinophilic Phenotype participants received Xolair per standard clinical practice	Non Eosinophilic Phenotype participants received Xolair per standard clinical practice
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eosinophilic Phenotype n=7 Participants participants received Xolair per standard clinical practice	Non Eosinophilic Phenotype n=6 Participants participants received Xolair per standard clinical practice	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
number of participants with eosinophilic or non eosinophilic (neutrophilic) sputum eosinophilic sputum	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
number of participants with eosinophilic or non eosinophilic (neutrophilic) sputum neutrophilic sputum	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
asthma severity severe	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
asthma severity moderate	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 32 weeks

sputum markers were classified as eosinophilic or non eosinophilic

Outcome measures

Outcome measures
Measure	Eosinophilic Phenotype n=7 Participants participants received xolair per standard practice	Non Eosinophilic Phenotype n=6 Participants participants received xolair per standard practice
Number of Participants With Change in Sputum Markers by End of Study	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 32 weeks

Outcome measures

Outcome measures
Measure	Eosinophilic Phenotype n=7 Participants participants received xolair per standard practice	Non Eosinophilic Phenotype n=6 Participants participants received xolair per standard practice
Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control	7 Participants	6 Participants

SECONDARY outcome

Timeframe: every 4 weeks up to 32 weeks

safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved

Outcome measures

Outcome measures
Measure	Eosinophilic Phenotype n=7 Participants participants received xolair per standard practice	Non Eosinophilic Phenotype n=6 Participants participants received xolair per standard practice
Number Participants for Whom Sputum Induction Was Safe	7 Participants	6 Participants

Adverse Events

Eosinophilic Phenotype

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Eosinophilic Phenotype

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MARIPAZ MORALES MD

CHILDREN'S HOSPITAL OF THE KING'S DAUGHTERS

Phone: 7576688255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place