Overview

This trial has been completed.

Condition asthma
Treatment omalizumab
Phase phase 4
Sponsor Hoffmann-La Roche
Start date June 2013
End date March 2016
Trial size 806 participants
Trial identifier NCT01922037, ML28528

Summary

This multicenter, prospective study will evaluate the correlation of participant's characteristics, including biomarkers, with predictive markers of clinical outcome in participants with moderate to severe asthma initiating treatment with omalizumab. During the 48 weeks, participants will be evaluated and treated per investigator discretion and will be followed from study entry until a maximum follow-up of 48 weeks, death, withdrawal of consent, loss to follow-up, or study closure.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants willing to initiate omalizumab treatment will receive omalizumab for 12 months as per investigator standard of care and clinical practice.
omalizumab Xolair
Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.

Primary Outcomes

Measure
Percentage of Participants With Protocol-Defined Composite Endpoints
time frame: Baseline until end of study/early termination (up to Month 12)

Secondary Outcomes

Measure
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)
Percentage of Participants Who Had Changes in Their Concomitant Asthma Medications
time frame: Baseline until end of study/early termination (up to Month 12)
Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)
Percentage of Participants whose Asthma was Controlled as Assessed by Asthma Control Test (ACT) Questionnaire
time frame: Baseline, Month 6, thereafter every month up to study completion/early termination (up to Month 12)
Work Productivity and Activity Impairment (WPAI) Scale Due to Asthma: Number of Days Missed From Work or school Due to Asthma
time frame: Baseline, Month 6, study completion/early termination (up to Month 12)
Percentage of Participants Who Showed an Improvement in Asthma Symptoms due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE)
time frame: Study completion/early termination (up to Month 12)
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
time frame: Baseline, study completion/early termination (up to Month 12)
Asthma-Related Urgent Health Care Utilization: Percentage of Participants With Exacerbations
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)
Asthma-Related Urgent Health Care Utilization: Percentage of Participants Who are Hospitalized
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)
Asthma-Related Urgent Health Care Utilization: Percentage of Participants Who Undergo Emergency Department Visits
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)
Asthma-Related Urgent Health Care Utilization: Percentage of Participants Who Undergo Acute Care Visits
time frame: Baseline, Months 6, study completion/early termination (up to Month 12)

Eligibility Criteria

Male or female participants at least 12 years old.

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 - 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

Additional Information

Official title A Prospective Observational Study To Evaluate Predictors of Clinical Response To Omalizumab
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.