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OpenTrials
Completed

NCT Number: NCT00219323

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

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

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Key information

Conditions

Asthma Bronchial Diseases Epilepsy, Idiopathic Generalized Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

This study is not being conducted in the United States

Tokyo, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omalizumab

Drug

Primary outcomes

  1. Safety of omalizumab

Secondary outcomes

  1. Pulmonary function parameters measured by spirometer

  2. Morning and evening peak expiratory flow (PEF)

  3. Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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