Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

NCT00267202 | Completed Phase 4 Results

• 1 other identifier: CIGE025AUS23
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent allergic asthma.

Conditions

Allergic Asthma

Keywords

Allergic Asthma, IgE, immunotherapy, omalizumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)

  The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Respiratory symptoms and Grade 4: Cardiovascular symptoms.

  26 Weeks

Secondary Outcomes (4)

• Severity of First Systemic Allergic Reaction (SAR)

  26 Weeks

• Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose

  16 Weeks

• Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen

  Up to 26 Weeks

• Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)

  Up to 26 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.

Drug: Placebo; Drug: Immunotherapy

Omalizumab

EXPERIMENTAL

The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.

Drug: Omalizumab; Drug: Immunotherapy

Interventions

Placebo DRUG

Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.

Placebo

Omalizumab DRUG

Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE.

Omalizumab

Immunotherapy DRUG

Customized allergen extracts were prepared centrally for each patient based on his/her specific skin test results. Four vials containing dilutions of the patient's extract were provided. Investigators initiated dosing according to the protocol for the cluster dosing titration regimen, beginning with vial #4 (the most dilute) and progressing to vial #1, which was the most concentrated or "maintenance" solution. Each dose was administered subcutaneously into the deltoid region as a single injection. During study visits that required multiple IT injections, each injection was to be given at least 30 minutes apart. During weeks that required multiple visits for IT injections, each visit was to be separated by at least 48 hours.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent
• Patients who were informed of the study procedures and medications and provided their written informed consent
• Demographics
• Male or female
• Any race
• Ages 18 - 55 years
• Body weight \>=20 kg and \<=150 kg
• Total serum IgE concentration \>=30 and \<=700 IU/mL at Visit 0
• Disease Definitions/Medications
• History of at least moderate persistent allergic asthma (consistent with Global Initiative for Asthma \[GINA\] guidelines of \>=1 year in duration
• On a stable asthma treatment regimen including inhaled corticosteroids for the preceding 4 weeks
• An FEV1 while withholding short-acting beta-agonists for at least 6 hours and long-acting beta-agonists for at least 12 hours, of \>=75% of the predicted value at Visit 0
• Evidence of reversible airway obstruction, as defined by an increase in FEV1 of \>=12% between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit 0 or within the preceding year
• Documented sensitivity to perennial aeroallergens, as evidenced by a positive skin test (wheal \>=5mm greater than saline control) to at least 1 of 3 perennial aeroallergens (house dust mite, cat, or dog) at Visit 0 or within the preceding year
• Average PEFR variability \<=20% (calculated as \[(PM PEF - AM PEF)/(PM PEF + AM PEF)/2 x 100) during the 2-week screening period

You may not qualify if:

• Patients were to be excluded from participation if they met any of the following criteria:
• Pulmonary
• History of intubation for asthma
• Asthma exacerbation requiring treatment with systemic steroids within the preceding 3 months
• Asthma exacerbation requiring treatment in an emergency department or a hospital admission in the preceding 6 months
• Upper respiratory tract infection or sinusitis within the preceding 4 weeks
• History of an anaphylactic allergic reaction (except to stinging insects, foods, or drugs other than omalizumab)
• History of treatment with immunotherapy to any allergen within past 3 years
• History of aspirin or non steroidal anti-inflammatory drug (NSAID)-related asthma; patients could have been included in NSAIDs use was avoided for the duration of the study
• General Medical
• History of or current malignancy
• Any clinically significant uncontrolled systemic disease or a history of such disease (e.g., infectious, hematologic, renal, hepatic, endocrinologic, gastrointestinal, or cardiovascular disease) within the previous 3 months
• Clinically significant laboratory abnormalities at Visit 1
• Platelet levels \<=130 x 10 9/L at visit 1
• Women of childbearing potential who were not practicing a medically approved contraception method (e.g., oral, subcutaneous, mechanical, or surgical contraception), as well as women who were pregnant or nursing

Sponsors & Collaborators

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

Study Sites (1)

Novartis

East Hanover, New Jersey, United States

Location

Related Links

• Novartis patient recruitment website

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized

Interventions

Omalizumab; Immunotherapy

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; Immunomodulation; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Director
• Organization: Novartis Pharmaceuticals

maria.figliomeni@novartis.com

862-778-1768

Study Officials

• Novartis

  Novartis

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 20, 2005
• Study Start: December 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 14, 2016
• Results First Posted: May 16, 2011

Record last verified: 2011-10

Locations

US (1)