A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab

Hoffmann-La Roche143 sites in 1 country806 target enrollmentJune 19, 2013

ConditionsAsthma

InterventionsOmalizumab

DrugsOmalizumab

Overview

Phase: Phase 4
Intervention: Omalizumab
Conditions: Asthma
Sponsor: Hoffmann-La Roche
Enrollment: 806
Locations: 143
Primary Endpoint: Total Number of Asthma Exacerbations During Months 1-12
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 19, 2013

End Date

March 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Participants With Allergic Asthma

Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.

Intervention: Omalizumab

Outcomes

Primary Outcomes

Total Number of Asthma Exacerbations During Months 1-12

Time Frame: Months 1-12

An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.

Secondary Outcomes

Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6(Months 1-6)
Total Number of Asthma-Related ER Visits During Months 7-12(Months 7-12)
Total Number of Asthma Exacerbations During Months 1-6(Months 1-6)
Total Number of Asthma-Related ER Visits During Months 1-12(Months 1-12)
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12(Months 1-12)
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6(Months 1-6)
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12(Months 7-12)
Percentage of Participants by Number of Asthma Exacerbations(Months 1-12)
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids(Months 1-12)
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)(Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12))
Total Number of Asthma Exacerbations During Months 7-12(Months 7-12)
Total Number of Asthma-Related Hospital Admissions During Months 7-12(Months 7-12)
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12(Months 1-12)
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6(Months 1-6)
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12(Months 7-12)
Total Number of Asthma-Related Hospital Admissions During Months 1-12(Months 1-12)
Total Number of Asthma-Related Hospital Admissions During Months 1-6(Months 1-6)
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score(Baseline, Month 6, EOS/ET (up to Month 12))
Change From Baseline in Raw Forced Vital Capacity (FVC)(Baseline, Month 6, EOS/ET (up to Month 12))
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)(Baseline, Month 6, EOS/ET (up to Month 12))
Change From Baseline in Percentage Predicted FEV1 (ppFEV1)(Baseline, Month 6, EOS/ET (up to Month 12))
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications(Baseline)
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications(Baseline until EOS/ET (up to Month 12))
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score(Baseline, Month 6, EOS/ET (up to Month 12))
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score(Baseline, EOS/ET (up to Month 12))
Change From Baseline in Asthma Control Test (ACT) Overall Score(Baseline, Months 3, 6, 9, 12)
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator(EOS/ET (up to Month 12))
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant(EOS/ET (up to Month 12))