Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
NCT ID: NCT01202903
Last Updated: 2015-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
616 participants
INTERVENTIONAL
2010-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Omalizumab
Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
Omalizumab
The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
Placebo
The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Placebo
The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Interventions
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Omalizumab
The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
Placebo
The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Shengyang, Liaoning, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Nanjing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Countries
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References
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Li J, Wang C, Liu C, Kang J, Kong L, Huang Y, Liu S, Huang M, Wang L, Fogel R, Jaumont X, Yang J, Zhong N. Efficacy predictors of omalizumab in Chinese patients with moderate-to-severe allergic asthma: Findings from a post-hoc analysis of a randomised phase III study. World Allergy Organ J. 2020 Nov 24;13(12):100469. doi: 10.1016/j.waojou.2020.100469. eCollection 2020 Dec.
Other Identifiers
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CIGE025A2313
Identifier Type: -
Identifier Source: org_study_id
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