Phase 4
N=419
Inner-City Anti-IgE Therapy for Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00377572 ↗Enrolled (actual)
419
Serious AEs
13.8%
Results posted
Jun 2013
Primary outcome: Primary: Maximum Number of Asthma Symptom Days — 1.48; 1.96 Days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- omalizumab (Biological); omalizumab placebo (Biological)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Number of Asthma Symptom Days |
1.48; 1.96 | <0.001 sig |
| SECONDARY Economic Outcome: Comparison of Number of Missed School Days Due to Asthma |
0.16; 0.25 | 0.04 sig |
| SECONDARY Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma |
0.13; 0.43 | 0.1111 |
| SECONDARY Child Asthma Control Test (C-ACT) Score |
23.0; 22.2 | 0.007 sig |
| SECONDARY Asthma Control Test (ACT) Score |
22.5; 22.3 | 0.54 |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) % Predicted |
92.6; 91.7 | 0.30 |
| SECONDARY FEV1/FVC Ratio |
77.3; 77.5 | 0.81 |
| SECONDARY Exhaled Nitric Oxide |
22.6; 33.0 | <0.0001 sig |
| SECONDARY Percent Adherence to Asthma Medication |
84.6; 88.6 | 0.12 |
| SECONDARY Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma) |
43.6; 26.7 | 0.001 sig |
| SECONDARY Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma) |
31.2; 50.8 | <0.001 sig |
| SECONDARY Dose Inhaled Corticosteroids (Glucocorticoids) |
663; 771 | <0.001 sig |
| SECONDARY Percent Prevalence: Prescribed Rescue Beta 2 Agonists |
55.4; 65.5 | 0.003 sig |
| SECONDARY Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations |
1.5; 6.3 | 0.02 sig |
| SECONDARY Percent Prevalence: Asthma Exacerbations |
30.3; 48.8 | <0.001 sig |
| SECONDARY Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall Score |
5.7; 5.8 | 0.84 |
| SECONDARY Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score |
6.1; 6.2 | 0.58 |
Summary
The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.
Eligibility Criteria
Inclusion Criteria
- Both body weight and total serum IgE suitable for omalizumab dosing.
- Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
- Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
- Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
- Live in a preselected zip code are
- Able to perform spirometry measurements
- Willing to sign informed consent or have parent or guardian willing to provide informed consent
- Previously had chicken pox or received varicella (chicken pox) vaccine
- Have some form of health care insurance that covers costs of medications
Exclusion Criteria
If participant meets any of these criteria, they are not eligible at that time but may be reassessed:
- Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
- Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
- Pregnancy or breastfeeding
- Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
- Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
- Does not sleep at least 4 nights per week in one home
- Lives with a foster parent
- Does not have access to a phone
- Plans to move during the study
- Previously treated with anti-IgE therapy within 1 year of study entry
- Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
- Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry
If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:
- Significant medical illness. More information on this criterion can be found in the protocol.
- Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
- Known hypersensitivity to any ingredients of omalizumab or related drugs
- Diagnosis of cancer, being investigated for possible cancer, or history of cancer
- Will not allow study physician to manage their asthma
- Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
- History of severe anaphylactoid or anaphylactic reaction(s)
Data sourced from ClinicalTrials.gov (NCT00377572). 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.