Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma - Full Text View

Sponsor:	Novartis Pharmaceuticals
Collaborator:	Genentech
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00870584

Purpose

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 NHBLI Guidelines

Condition	Intervention	Phase
Persistent Allergic Asthma	Drug: Xolair Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	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

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:

Omalizumab effect on markers of impairment measured by change from baseline in Asthma Control Test (ACT) after 24 weeks of treatment, in patients with inadequately controlled persistent allergic asthma on Step 4 or above as in 2007 NHLBI Guidelines [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effect of omalizumab on clinical symptoms as measured by Investigator Global Evaluation of Treatment Effectiveness (IGETE) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of omalizumab using the Work Productivity and Activity Impairment - Asthma (WPAI-A) Questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of omalizumab on individual criteria of impairment (daytime asthma symptoms, nighttime awakenings, short-acting beta2-agonist use and FEV1) as described in the 2007 NHLBI guidelines [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	271
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Xolair	Drug: Xolair
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Total 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
- SABA use for symptom control >2 days/week 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870584

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Sponsors and Collaborators

Novartis Pharmaceuticals

Genentech

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CIGE025AUS33
Study First Received:	March 25, 2009
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00870584 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Asthma; asthma management; asthma impairment ; Xolair ; omalizumab

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on February 08, 2010