A study of efficacy of humanized anti-human IgE monoclonal antibody, omalizumab for the treatment of severe nonatopic asthma

A study of efficacy of humanized anti-human IgE monoclonal antibody, omalizumab for the treatment of severe nonatopic asthma - Omalizumab for severe nonatopic asthma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005723

Enrollment

Registered

2011-06-06

Start date

2010-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Bronchial asthma

Interventions

Treatment with anti-IgE antibody, omalizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Severe nonatopic asthma patients who required sysytemic corticosteroid rescue at least 1 time during 6-momth observation period despite optimal treatment including inhaled corticosteroid

Exclusion criteria

Exclusion criteria: Patients with active cardiopulmonary diseases other than bronchial asthma or serious medical conditions (e.g. malignancy)

Design outcomes

Primary

Measure	Time frame
Change in the number of unscheduled hospital visit and systemic corticosteroid rescue for exacerbation of asthma during in 6-month observation and 6-month treatment period	—

Secondary

Measure	Time frame
Change in Asthma Control Test(ACT) score, forced expiratory volume in 1 second, fractional exhaled nitric oxide concentration before and after omalizumab treatment	—

Countries

Japan

Contacts

Public ContactMikio Toyoshima

Hamamatsu Rosai Hospital Department of Respiratory Medicine

053-462-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026