Overview

This trial is active, not recruiting.

Condition asthma
Sponsor Hoffmann-La Roche
Start date June 2013
End date March 2016
Trial size 807 participants
Trial identifier NCT01922037, ML28528

Summary

This observational study will evaluate the correlation of patient's characteristics with predictive markers of clinical outcome in patient with moderate to severe asthma initiating treatment with Xolair (omalizumab). Data will be collected for 48 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Clinical/demographic patient characteristics (concomitant medication, asthma exacerbation, lung function, quality of life) at initiation of treatment
time frame: 48 weeks

Secondary Outcomes

Measure
Correlation of patient's characteristics (concomitant medication, asthma exacerbation, lung function, quality of life) with clinical outcome at initiation of treatment
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Patients, age >= 12 years - Patients identified by the investigator as a candidate for treatment for asthma with omalizumab - Able and willing to provide written informed consent - Signed Authorization for the Use and Disclosure of Health Information - Confirmation of access to omalizumab through insurance or other source of funding Exclusion Criteria: - Enrollment in any other concurrent clinical trial or observational study (with the exception of the EXPECT pregnancy registry) - Patients for whom omalizumab treatment is contraindicated - Patients treated with omalizumab within the previous year

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 March 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.