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

This study is currently recruiting participants.

Verified May 2013 by Novartis

Sponsor:

Collaborator:

Genentech

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01202903

First received: September 14, 2010

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Persistent Allergic Asthma	Drug: Omalizumab Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Effect of add-on omalizumab versus add-on placebo on lung function, as measured by change from baseline in mean morning peak expiratory flow (PEF) following the 24-week treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety and tolerability of omalizumab [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Effect of add-on omalizumab versus add-on placebo on: change from baseline in: FEV1 percent predicted, PEF, overall score of the standardized AQLQ, ACQ, investigators' and patients' GETE, total nocturnal, daytime and morning asthma symptom scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	610
Study Start Date:	September 2010
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Omalizumab	Drug: Omalizumab
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202903

Contacts

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Show 43 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Genentech

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01202903 History of Changes
Other Study ID Numbers:	CIGE025A2313
Study First Received:	September 14, 2010
Last Updated:	May 13, 2013
Health Authority:	China: Ethics Committee (central and local) China: Food and Drug Administration China: Human Genetic Resource Administration of China

Keywords provided by Novartis:

omalizumab
asthma
immunoglobulin E
IgE

Additional relevant MeSH terms:

Bronchial Diseases
Asthma
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 May 21, 2013

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