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Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

NCT00870584•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
•* Symptoms \> 2 days/week
•* Night-time awakenings ≥1 time/week
•* Short-acting beta2-agonist (SABA) use for symptom control \>2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted

Exclusion Criteria

•History of intubation for asthma.
•An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
•Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Locations (50)

Jasper Summit Research, LLC

Jasper, Alabama, United States

Allergy Asthma and Immunology Center of Alaska

Anchorage, Alaska, United States

Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD

Scottsdale, Arizona, United States

Waren W. Pleskow, MD

Encinitas, California, United States

William Ebbeling, MD, Inc

Fresno, California, United States

Pediatric Care Medical Group, Inc

Huntington Beach, California, United States

California Allergy & Asthma Medical Group

Palmdale, California, United States

Allergy Associates Medical Group, Inc

San Diego, California, United States

Sansum Clinic

Santa Barbara, California, United States

Allergy & Asthma Clinical Research, Inc.

Walnut Creek, California, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

November 17, 2011

Enrollment

271

ACTUAL participants

Conditions

Persistent Allergic Asthma

Interventions

Omalizumab

DRUG

Placebo

DRUG

Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

NCT01202903

Persistent Allergic Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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