Study of Omalizumab in Moderate to Severe Bronchial Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232050

Enrollment

327

Registered

2005-10-04

Start date

2002-10-31

Completion date

2005-05-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, IgE, Omalizumab

Brief summary

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

Interventions

DRUGOmalizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Inclusion criteria

* Allergic asthma patients * Inadequately controlled patients

Exclusion criteria

* \- History of severe anaphylactoid or anaphylactic reactions * Previous treatment with omalizumab * History of cancer or cancer Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Morning peak expiratory flow (PEF) at baseline and end of treatment.	—

Secondary

Measure	Time frame
Pulmonary function parameters measured by spirometer	—
Frequency of rescue medication use	—
Symptom score	—
Activities of daily living score	—
Nighttime sleep score	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026