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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01202903
First received: September 14, 2010
Last updated: January 27, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 610
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab
Participants will receive Omalizumab
Drug: Omalizumab
Omalizumab
Placebo Comparator: Placebo
Participants will receive Placebo
Drug: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 39 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Genentech
Investigators
Study Director: Novartis Pharmaceuticals 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: January 27, 2014
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:
Asthma
Bronchial Diseases
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 July 24, 2014