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

This study has been completed.
Sponsor:
Collaborators:
Genentech
Novartis
Information provided by (Responsible Party):
Emily DiMango, DiMango, Emily, M.D.
ClinicalTrials.gov Identifier:
NCT00180011
First received: September 10, 2005
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Omalizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

Resource links provided by NLM:


Further study details as provided by DiMango, Emily, M.D.:

Primary Outcome Measures:
  • Asthma symptom utility index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omaluzimab Drug: Omalizumab
injectable medication

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180011

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
DiMango, Emily, M.D.
Genentech
Novartis
Investigators
Principal Investigator: Emily DiMango, MD Columbia University
  More Information

No publications provided

Responsible Party: Emily DiMango, Assistant Professor, DiMango, Emily, M.D.
ClinicalTrials.gov Identifier: NCT00180011     History of Changes
Other Study ID Numbers: 20041332
Study First Received: September 10, 2005
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by DiMango, Emily, M.D.:
omalizumab
severe asthma
moderate asthma
injectable asthma medication
Xolair

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 19, 2014