Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00567476

Purpose

This study investigates asthma-related quality of life in Brazilian patients using omalizumab.

Condition	Intervention	Phase
Asthma	Drug: Omalizumab Drug: conventional therapy	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab Immunoglobulins Globulin, Immune Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Further study details as provided by Novartis:

Primary Outcome Measures:

Patient's quality of life assessed by Asthma Quality of Life Questionnaire score

Secondary Outcome Measures:

•Episodes of asthma exacerbation during 5 months of treatment •Efficacy assessed by asthma exacerbation data, patient diary cards, rescue medication use, clinical symptoms scores, global evaluations, pulmonary function. •Safety assessed by adverse

Estimated Enrollment:	123
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Active Comparator	Drug: Omalizumab conventional therapy (inhaled corticosteroids and long acting beta agonist) and Omalizumab
2: Active Comparator	Drug: conventional therapy conventional therapy (inhaled corticosteroids and long acting beta agonist)

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

12 to 75 years-old during screening visit.
Body weight > 20 kg and < 150kg.
Daily or persistent asthma symptoms.
Night symptoms at least once a week.
Forced Expiratory Volume in 1 second (FEV1) > 40% and < 80% of predicted normal value and continuing asthma symptoms.
FEV1 increased > 12% from baseline within 30 minutes of inhaled (up to 400 mcg) or nebulized (up to 5 mg) salbutamol.
Subject taking more than 500mcg/day of fluticasone or equivalent associated to a long-acting β2-agonist.
Inhaled corticosteroid and LABA doses must remain fixed during the last 12 weeks prior to visit 2.
Medical history of at least two episodes of asthma exacerbation treated with systemic corticoid or at least one severe asthma exacerbation treated with systemic corticoid and hospitalization or emergence room visit in the last 12 months prior to screening visit.
Positive skin prick test (diameter of wheal > 3mm) to at least one perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to which the subject is likely to be exposed during the study.
Subject capable to read and understand Asthma Related quality of life questionnaire (Juniper's questionnaire).

Exclusion Criteria:

Pregnant, nursing female subjects.
Female subjects without current acceptable contraceptive method.
Previous history of allergy or hypersensitivity to Omalizumab.
Subjects with prior treatment with Omalizumab.
Subjects with medical history of psychiatric disorder.
Subject has been treated with systemic corticosteroid for any reason other than asthma.
Subject took β2 antagonist medication in the last 3 months prior to screening visit.
Subject took protocol prohibited medication prior to screening
Medical history of food or drug related severe anaphylactoid reactions.
Medical history of antibiotics allergy. Patients may be included if the antibiotics to which they are allergic to will be avoided for the entire duration of the study.
Asthma related to non-steroidal anti-inflammatory drug (NSAID).
Treatment of exacerbation in the 4 weeks prior to randomization.
Other active lung diseases.
Medical history of others uncontrolled diseases 3 months prior randomization (eg. infections, coronary heart diseases and metabolic diseases).
Any history of cancer.
Abnormal electrocardiogram (ECG), laboratory exams (clinically significant abnormalities) and chest X-ray (CXR).
Evidence or history of drug or alcohol abuse.
Airway infection (eg. pneumonia, acute sinusitis) 4 weeks prior to screening visit
Smokers or smoking history of > 10 pack-years.
Subject that has been treated with investigational drugs over the past 30 days or during the course of the trial.
Subject with elevated IgE levels for reasons other than allergy.
Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567476

Contacts

Contact: Novartis

41 61 324 1111

Locations

Brazil
Novartis Investigator Site	Recruiting
São Paulo, Brazil
Contact 41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma

More Information

Responsible Party:	Novartis ( External affairs )
Study ID Numbers:	CIGE025ABR01
Study First Received:	December 4, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00567476
Health Authority:	Brazil: Ministry of Health

Keywords provided by Novartis:

Asthma, anti-immunoglobulin E, omalizumab

Study placed in the following topic categories:

Antibodies
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Quality of Life
Asthma
Immunoglobulins
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009