ALLERGIC ASTHMA
Conditions
Brief 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)
Detailed description
Objectives: Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy. Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT Hypotheses: Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics. Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well. Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.
Interventions
DRUGANTI-IGE THERAPY (XOLAIR)
Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
Sponsors
Novartis
Genentech, Inc.
Children's Hospital of The King's Daughters
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change in Sputum Markers by End of Study | 32 weeks | sputum markers were classified as eosinophilic or non eosinophilic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control | 32 weeks | — |
| Number Participants for Whom Sputum Induction Was Safe | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eosinophilic Phenotype participants received Xolair per standard clinical practice | 7 |
| Non Eosinophilic Phenotype participants received Xolair per standard clinical practice | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Eosinophilic Phenotype | Non Eosinophilic Phenotype | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| asthma severity moderate | 2 Participants | 4 Participants | 6 Participants |
| asthma severity severe | 5 Participants | 2 Participants | 7 Participants |
| number of participants with eosinophilic or non eosinophilic (neutrophilic) sputum eosinophilic sputum | 7 Participants | 0 Participants | 7 Participants |
| number of participants with eosinophilic or non eosinophilic (neutrophilic) sputum neutrophilic sputum | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Number of Participants With Change in Sputum Markers by End of Study
sputum markers were classified as eosinophilic or non eosinophilic
Time frame: 32 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eosinophilic Phenotype | Number of Participants With Change in Sputum Markers by End of Study | 0 Participants |
| Non Eosinophilic Phenotype | Number of Participants With Change in Sputum Markers by End of Study | 0 Participants |
Secondary
Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control
Time frame: 32 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eosinophilic Phenotype | Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control | 7 Participants |
| Non Eosinophilic Phenotype | Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control | 6 Participants |
Secondary
Number Participants for Whom Sputum Induction Was Safe
safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved
Time frame: every 4 weeks up to 32 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eosinophilic Phenotype | Number Participants for Whom Sputum Induction Was Safe | 7 Participants |
| Non Eosinophilic Phenotype | Number Participants for Whom Sputum Induction Was Safe | 6 Participants |