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

NCT01202903 | Completed Phase 3 Results

• 1 other identifier: CIGE025A2313
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 39

Brief 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.

Conditions

Persistent Allergic Asthma

Keywords

omalizumab; asthma; immunoglobulin E; IgE

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period

  A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.

  Baseline, 24 weeks

Secondary Outcomes (9)

• Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment

  Baseline, 24 weeks

• Change From Baseline in % Predicted FEV1 Following 24-week Treatment

  Baseline, 24 weeks

• Change From Baseline in AQLQ Score Following 24-week Treatment

  24 weeks

• Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment

  24 weeks

• Change From Baseline in ACQ Score Following 24-week Treatment

  24 weeks

Study Arms (2)

Omalizumab

EXPERIMENTAL

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.

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Omalizumab DRUG

The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.

Omalizumab

Placebo DRUG

The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Genentech, Inc.: collaborator

Study Sites (39)

Novartis Investigative Site

Beijing, Beijing Municipality, 100023, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510030, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510515, China

Location

Novartis Investigative Site

Nanning, Guangxi, 530021, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430070, China

Location

Novartis Investigative Site

Changsha, Hunan, 410003, China

Location

Novartis Investigative Site

Changsha, Hunan, 410008, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215006, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Changchun, Jilin, 130041, China

Location

Novartis Investigative Site

Shengyang, Liaoning, 110016, China

Location

Novartis Investigative Site

Shenyang, Liaoning, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200433, China

Location

Novartis Investigative Site

Xian, Shanxi, 710004, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710038, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310003, China

Location

Novartis Investigative Site

Beijing, 100029, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100050, China

Location

Novartis Investigative Site

Beijing, 100088, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Beijing, China

Location

Novartis Investigative Site

Chongqing, 400037, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Chongqing, 400042, China

Location

Novartis Investigative Site

Guangzhou, 510080, China

Location

Novartis Investigative Site

Nanjing, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Shanghai, 200233, China

Location

Novartis Investigative Site

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 34611470 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2015-03

Locations

CN (39)