Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

July 31, 2017 updated by: Novartis Pharmaceuticals

Ph III, 28-wk, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess Efficacy, Safety, Tolerability of SC Omalizumab in Adults and Adolescents w/ Severe Persist. Allergic Asthma & Are Inadequately Controlled Despite GINA (2002) Step 4 Tx

The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • with the diagnosis of allergic asthma >1 year duration who, in addition to the standards of the American Thoracic Society (ATS) meet the following criteria:
  • with a positive prick skin test (diameter of wheal > 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A RAST test may be performed for patients with a borderline skin prick test result.
  • with total serum IgE level 30 to 700 IU/ml.
  • demonstrating 12% increase in FEV1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative B-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization.
  • with FEV1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours after long acting B-2 agonist use) at baseline.
  • who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year.

or:

  • been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the GINA guidelines met all of the following criteria for a severe exacerbation:

    1. PEF or FEV1< 60% of predicted/personal best, or patient is too breathless to provide PEF.
    2. No improvement after initial treatment and therefore requiring repeated treatment with inhaled B-2 agonist (high dose, spacer or nebulized).
    3. Requiring treatment with systemic corticosteroids
  • receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting B-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/ER visit.
  • who are receiving an ICS dosage > 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting B-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study).
  • whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study).
  • with evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinically significant asthma exacerbation

Secondary Outcome Measures

Outcome Measure
Quality of Life assessment at baseline, last visit
Medical resource utilization
Time to first asthma exacerbation
Frequency of asthma rescue medication use
Safety/tolerability of omalizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

October 2, 2002

First Submitted That Met QC Criteria

October 3, 2002

First Posted (Estimate)

October 4, 2002

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025A2306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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