A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Roche

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922037

ML28528

Details and patient eligibility

About

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.

Enrollment: 806 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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806 participants in 1 patient group

Participants With Allergic Asthma

Experimental group

Description:

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.

Treatment:

Drug: Omalizumab