Loading clinical trials...

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

COMPLETEDPHASE3

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

A 24-week, Phase III Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study of Xolair® (Omalizumab) in Patients With Moderate to Severe Persistent Allergic Asthma Who Remain Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

NCT01202903•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight \> 20 kg and ≤ 150 kg)
•Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
•Received medium-to-high dose inhaled corticosteroid \> 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
•Met specific asthma exacerbations eligibility criteria prior to the screening period
•Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
•Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
•FEV1 ≥ 40% and \< 80% of the predicted normal value for the patient (using local standards), after withholding bronchodilators at Visit 2

Exclusion Criteria

•Used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. For biological agent-based investigational drugs, such as monoclonal antibodies, at least six months will need to have passed between the last administration of the drug and the patient's Screening Visit.
•History of malignancy
•History of allergies and diseases that could interfere with the analyses
•Clinically significant abnormality on a 12-lead ECG recorded at Visit 1
•Elevated IgE levels for reasons other than allergy
•Current smokers, or a former smoker with a smoking history of \> 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
•Receiving specific medications
•Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1

Locations (39)

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Nanning, Guangxi, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Changsha, Hunan, China

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 23, 2015

Enrollment

616

ACTUAL participants

Conditions

Persistent Allergic Asthma

Interventions

Omalizumab

DRUG

Placebo

DRUG

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

NCT00870584

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: March 23, 2015Data 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.

View ClinicalTrials.gov Terms and Conditions