Effect of Xolair on Airway Hyperresponsiveness

NCT00208234 | Unknown Phase 4

• 1 other identifier: Xolair Asthma
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Conditions

Allergic Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• To determine if treatment with omalizumab induces changes in PC20 values to methacholine bronchoprovocation challenges and/or PC15 values to hypertonic saline-induced bronchoprovocation challenges in a time-dependent manner in steroid naive subjects

  post treatment

Secondary Outcomes (1)

• Determine in steroid naive allergic asthma subjects whether omalizumab decreases exhaled NO and sputum eosinophilia, markers of airway inflammation, in time-dependent fashion and to correlate these effects with those measured for airway responsiveness

  post treatment

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo for Omalizumab

2

EXPERIMENTAL

Omalizumab

Drug: Omalizumab

Interventions

omalizumab DRUG

0.016 mg/kg IgE

Also known as: Xolair, rHuMAbE25

2

Placebo for Omalizumab DRUG

Placebo

Control

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.
• History of mild to moderate asthma
• A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)
• A PC20 value for methacholine \< 5 mg/mL
• A PC15 value for hypertonic saline at \< 4 minutes
• Capable of faithfully attending regularly scheduled study visits
• Willing to avoid prohibited medications for the periods indicated in the protocol
• A baseline serum IgE level of \> 30 IU/mL and \< 700 IU/mL

You may not qualify if:

• Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding
• Known sensitivity to study drug or class of study drug
• Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit
• Patients with a history of severe anaphylactoid or anaphylactic reactions
• Patients taking beta-adrenergic antagonists in any form
• Patients previously exposed to Xolair
• Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs
• Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations
• Use of immunosuppressive medications
• History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

Sponsors & Collaborators

• Creighton University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Creighton University Division of Allergy & Immunology

Omaha, Nebraska, 68131, United States

Location

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

Study Officials

• Thomas B Casale, MD

  Creighton University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

US (1)