NCT00232050

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Oct 2002

Typical duration for phase_3 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

2.6 years

First QC Date

October 3, 2005

Last Update Submit

October 24, 2011

Conditions

Asthma

Keywords

Asthma, IgE, Omalizumab

Outcome Measures

Primary Outcomes (1)

  • Morning peak expiratory flow (PEF) at baseline and end of treatment.

Secondary Outcomes (5)

  • Pulmonary function parameters measured by spirometer

  • Frequency of rescue medication use

  • Symptom score

  • Activities of daily living score

  • Nighttime sleep score

Interventions

OmalizumabDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Allergic asthma patients
  • Inadequately controlled patients

You may not qualify if:

  • \- History of severe anaphylactoid or anaphylactic reactions
  • Previous treatment with omalizumab
  • History of cancer or cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaEpilepsy, Idiopathic Generalized

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals Japan

    Novartis Pharmaceuticals Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

October 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

October 25, 2011

Record last verified: 2011-10