Phase 4
Completed N=806
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
Source: ClinicalTrials.gov NCT01922037 ↗Enrolled (actual)
806
Serious AEs
11.2%
Results posted
Dec 2017
Primary outcomePrimary: Total Number of Asthma Exacerbations During Months 1-12 — 0.46; 0.81; 0.78 asthma exacerbations
◆ Published Evidence
Established
20citations · ~4 / year
Omalizumab response in patients with asthma by number and type of allergen.
Summary
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.
Linked Publications (5)
-
Omalizumab response in patients with asthma by number and type of allergen.
-
No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities.
-
Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma?
-
Effectiveness of omalizumab across different dosing regimens in patients with moderate-to-severe allergic asthma.
-
Omalizumab treatment reduces asthma exacerbations regardless of airway bronchodilator reversibility.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Asthma Exacerbations During Months 1-12 |
0.46; 0.81; 0.78 | — |
| SECONDARY Total Number of Asthma Exacerbations During Months 1-6 |
0.20; 0.51; 0.48 | — |
| SECONDARY Total Number of Asthma Exacerbations During Months 7-12 |
0.29; 0.35; 0.35 | — |
| SECONDARY Total Number of Asthma-Related Hospital Admissions During Months 1-12 |
0.04; 0.06; 0.06 | — |
| SECONDARY Total Number of Asthma-Related Hospital Admissions During Months 1-6 |
0.03; 0.03; 0.03 | — |
| SECONDARY Total Number of Asthma-Related Hospital Admissions During Months 7-12 |
0.02; 0.03; 0.03 | — |
| SECONDARY Total Number of Asthma-Related ER Visits During Months 1-12 |
0.13; 0.14; 0.14 | — |
| SECONDARY Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 |
0.04; 0.09; 0.09 | — |
| SECONDARY Total Number of Asthma-Related ER Visits During Months 7-12 |
0.10; 0.06; 0.06 | — |
| SECONDARY Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 |
0.39; 0.39; 0.39 | — |
| SECONDARY Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 |
0.23; 0.23; 0.23 | — |
| SECONDARY Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 |
0.17; 0.18; 0.18 | — |
| SECONDARY Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12 |
0.35; 0.43; 0.43 | — |
| SECONDARY Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6 |
0.16; 0.24; 0.23 | — |
| SECONDARY Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12 |
0.21; 0.22; 0.22 | — |
| SECONDARY Percentage of Participants by Number of Asthma Exacerbations |
69.6; 61.8; 62.4; 18.8; 18.3; 18.3 | — |
| SECONDARY Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids |
71.0; 62.3; 63.1; 20.3; 18.2; 18.3 | — |
| SECONDARY Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) |
2.61; 2.24; 2.27; 0.09; 0.06; 0.06 | — |
| SECONDARY Change From Baseline in Raw Forced Vital Capacity (FVC) |
3.36; 3.08; 3.11; 0.09; 0.07; 0.07 | — |
| SECONDARY Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) |
3.96; 2.28; 2.42; -1.66; -0.44; -0.55 | — |
| SECONDARY Change From Baseline in Percentage Predicted FEV1 (ppFEV1) |
87.89; 74.23; 75.38; 2.72; 1.77; 1.86 | — |
| SECONDARY Percentage of Participants With Prior Asthma Medications by Category or Class of Medications |
98.6; 99.3; 99.3; 91.3; 88.6; 88.8 | — |
| SECONDARY Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications |
100.0; 99.2; 99.3; 91.3; 89.4; 89.6 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score |
4.71; 3.93; 4.00; 0.94; 1.18; 1.16 | — |
| SECONDARY Change From Baseline in Asthma Control Test (ACT) Overall Score |
16.40; 13.71; 13.94; 3.11; 3.58; 3.54 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score |
10.37; 7.70; 7.72; 0.00; -3.31; -3.30 | — |
| SECONDARY Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator |
81.0; 75.8; 76.3 | — |
| SECONDARY Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant |
87.3; 75.0; 76.1 | — |
| SECONDARY Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score |
2.44; 2.76; 2.73; -1.17; -0.99; -1.01 | — |
Eligibility Criteria
Inclusion Criteria
- Participants identified by the investigator as a candidate for treatment for asthma with omalizumab
- Confirmation of access to omalizumab through insurance or other source of funding
Exclusion Criteria
- Enrollment in any other concurrent clinical trial or observational study
- Participants for whom omalizumab treatment is contraindicated
- Participants who had a prior allergic reaction to omalizumab or its excipients
- Participants treated with omalizumab within the previous year
- Participants who received an experimental drug as part of another study within 3 months of enrollment
Data sourced from ClinicalTrials.gov (NCT01922037) and the linked publication. 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.