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OpenTrials
Completed

NCT Number: NCT00180011

Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.

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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–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Columbia University

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-30
  • Minority Patients
  • Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)]. Allergic asthma will be defined as elevated IgE level (> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
  • asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
  • FEV1 50-90% predicted at screening and randomization visit

Exclusion criteria

  • Active smoking within one year and/or greater than 10-pack year history of smoking
  • Women of childbearing age must be using effective contraception
  • Malignancy diagnosed within the past 5 years
  • Underlying lung disease other than asthma
  • Inability to comply with study protocol

Treatment and study plan

Omalizumab

Drug

injectable medication

Primary outcomes

  1. Asthma symptom utility index

    Time frame: 6 months

Secondary outcomes

  1. Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

DiMango, Emily, M.D.

Indiv

Collaborators

  • Genentech, Inc.
  • Novartis

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2005
Registry last updated
Feb 28, 2012

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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