Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

NCT00264849 | Completed Phase 4 Results

• 1 other identifier: CIGE025A2425
• Study Type: interventional
• Target: 406
• Locations: 17 countries
• Sites: 17

Brief Summary

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Conditions

Asthma

Keywords

Asthma; omalizumab; Severe persistent allergic asthma

Outcome Measures

Primary Outcomes (1)

• Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)

  Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.

  Weeks 16 and 32

Secondary Outcomes (13)

• Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32

  Weeks 16 and 32

• Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE

  Weeks 16 and 32

• Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32

  Weeks 16 and 32

• Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE

  Weeks 16 and 32

• Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)

  Weeks 16 and 32

Study Arms (2)

OAT + Omalizumab

EXPERIMENTAL

During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.

Drug: Omalizumab; Other: Optimized asthma therapy

Optimized Asthma Treatment (OAT)

ACTIVE COMPARATOR

During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.

Other: Optimized asthma therapy

Interventions

Omalizumab DRUG

Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.

Also known as: Xolair

OAT + Omalizumab

Optimized asthma therapy OTHER

Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.

OAT + Omalizumab; Optimized Asthma Treatment (OAT)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the following criteria were included:
• Males or females of any race, who were 12-75 years of age
• A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
• A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
• A positive prick skin test (diameter of wheal \>= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
• Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
• An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
• Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists for at least 3 months prior to screening and \> 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at randomization
• Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
• Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation

You may not qualify if:

• Patients who met the following criteria were excluded:
• Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
• A smoking history \>10 pack years
• An active lung disease other than allergic asthma
• Elevated serum IgE levels for reasons other than allergy
• Patients with significant underlying medical conditions

Sponsors & Collaborators

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

Study Sites (17)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Montreal, Canada

Location

Unknown Facility

Hvidovre, Denmark

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lisbon, Portugal

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Bern, Switzerland

Location

Unknown Facility

Bursa, Turkey (Türkiye)

Location

Unknown Facility

Nottingham, United Kingdom

Location

Related Publications (1)

• Siergiejko Z, Swiebocka E, Smith N, Peckitt C, Leo J, Peachey G, Maykut R. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin. 2011 Nov;27(11):2223-8. doi: 10.1185/03007995.2011.620950. Epub 2011 Sep 21.

  PMID: 21933100 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 CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: November 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 29, 2018
• Results First Posted: July 25, 2011

Record last verified: 2018-04

Locations

BE (1); GB (1); HU (1); IL (1); IT (1); PT (1); NO (1); GR (1); ES (1); TU (1); PL (1); SE (1); CH (1); CA (1); DE (1); IE (1); DK (1)