Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046748
• Other study ID #: CIGE025A2306
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2002
• Last updated: July 31, 2017
• Start date: December 2001
• Est. completion date: April 2004

Study information

• Verified date: July 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant asthma exacerbation
Secondary	Medical resource utilization
Secondary	Time to first asthma exacerbation
Secondary	Quality of Life assessment at baseline, last visit
Secondary	Frequency of asthma rescue medication use
Secondary	Safety/tolerability of omalizumab

External Links

•   Results for CIGE025A2306 from the Novartis Clinical Trials Website