Study of Omalizumab in Moderate to Severe Bronchial Asthma

This study has been completed.

First Received: October 3, 2005 Last Updated: August 14, 2006 History of Changes

Sponsors and Collaborators:	Novartis Daiichi Sankyo Co., Ltd.
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232050

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Omalizumab	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Omalizumab in Moderate to Severe Bronchial Asthma

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Start Date:

October 2002

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: NCT00232050

Sponsors and Collaborators

Novartis

Daiichi Sankyo Co., Ltd.

Investigators

Study Chair:

Novartis Pharmaceuticals Japan

More Information

No publications provided

Study ID Numbers:	CIGE025A1304
Study First Received:	October 3, 2005
Last Updated:	August 14, 2006
ClinicalTrials.gov Identifier:	NCT00232050 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 May 07, 2009