Effect of Anti-IgE in Non-Allergic Asthma

NCT00162773 | Terminated Phase 2 Results

• 1 other identifier: 04-10-25-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if omalizumab is effective in treating non-allergic asthma. The US Food and Drug Administration has approved the use of omalizumab to treat moderate to severe allergic asthma.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Changes in Free Serum IgE Levels From Baseline

  baseline to 2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

water injection

Other: Placebo

Omalizumab

EXPERIMENTAL

Other Names: Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.

Drug: omalizumab

Interventions

omalizumab DRUG

150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.

Also known as: Xolair

Omalizumab

Placebo OTHER

150-375 milligrams depending on body weight and serum IgE.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-breastfeeding females 18 through 80 years of age
• Clinically acceptable ECG
• Diagnosis of moderate to severe persistent asthma
• History or presence of episodic symptoms of airflow obstruction (wheeze, chest tightness, cough, shortness of breath)
• Airflow obstruction is at least partially reversible
• FEV1 in the context of this study is \<80%of predicted values at visit 1 with no short-acting ß agonist use within 6 hours of spirometry
• Improvement of at least 12% of predicted FEV1 value and at least 200 ml within 15 to 30 minutes of inhaling nebulized albuterol (up to 5mg) or 2-4 puffs of albuterol (90 mcg/actuation) demonstrated at study entry or documented in the last year.
• Subjects must be able to demonstrate proper technique for use of the MiniWright peak flow meter
• Subjects must have a negative skin test to the 5 common perennial aeroallergens (D. farinae, D. pteronyssinus, cat, dog, and cockroach) at prick puncture with an adequate histamine control.
• Subjects must have negative RAST to the same 5 common perennial aeroallergens .
• Serum total IgE must be 30-700 IU/ml.
• Normal EKG at baseline
• Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using one of the following medically acceptable forms of birth control throughout the duration of the study:
• Systemic contraceptives
• Diaphragm with intravaginal spermicide

You may not qualify if:

• Respiratory tract infection within 14 days prior to Visit 1
• Chronic bronchitis, COPD, emphysema and other chronic lung diseases
• Receiving immunotherapy other than maintenance therapy
• Current smokers
• Current use of Xolair®
• Recent history of drug or alcohol abuse (within 3 years prior to Visit 1)
• Pregnant or likely to become pregnant during the study
• Breast-feeding
• History of hypersensitivity to albuterol, or Xolair, or to drugs with similar chemical structures
• Treatment with any investigational drug in the last 30 days before enrollment into the study (Visit 1)
• Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease making the protocol or interpretation of the study results difficult
• Site staff members or their immediate families are not eligible to enroll

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, 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

Results Point of Contact

• Title: Clinical Trials Program JHU ICTR
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Study Officials

• Peter S Creticos, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-07

Locations

US (1)