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OpenTrials
Completed

NCT Number: NCT00329381

Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis and history of moderate persistent allergic asthma
  • body weight >/= 20kg and </= 150kg
  • Total serum IgE >/= 30 and </= 700IU/mL
  • on a stable asthma treatment including corticosteroids for the preceding 4 weeks
  • non smoker for at least 1 year prior to visit 1

Exclusion criteria

  • patients with severe asthma
  • history of immunotherapy to any allergen within the past 3 years
  • history of anaphylactic allergic reaction
  • upper respiratory tract infection

Treatment and study plan

Xolair

Drug

Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Other names: Omalizumab (Xolair)

Primary outcomes

  1. Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids

    Time frame: 2005-2007

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • Novartis

Registry information

Official study title

A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 24, 2006
Registry last updated
Jun 4, 2008

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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