Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

This study has been completed.

First Received: September 21, 2005 Last Updated: June 11, 2007 History of Changes

Sponsors and Collaborators:	Novartis Daiichi Sankyo Co., Ltd.
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219323

Purpose

This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Condition	Intervention	Phase
Asthma	Drug: Omalizumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety of omalizumab

Secondary Outcome Measures:

Pulmonary function parameters measured by spirometer
Morning and evening peak expiratory flow (PEF)
Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

Study Start Date:

September 2003

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

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 exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219323

Locations

Japan
This study is not being conducted in the United States
Tokyo, Japan

Sponsors and Collaborators

Novartis

Daiichi Sankyo Co., Ltd.

Investigators

Study Chair:

Novartis Pharmaceuticals Japan

More Information

No publications provided

Study ID Numbers:	CIGE025A1307
Study First Received:	September 21, 2005
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00219323 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Asthma, IgE, Omalizumab

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate

Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on September 01, 2009