A Study to Evaluate the Efficacy of Xolair in Atopic Asthmatics

Condition(s) targeted: Asthma

Intervention: omalizumab (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Genentech

Official(s) and/or principal investigator(s):
Karin Rosen, M.D., Study Director, Affiliation: Genentech

Overall contact:
Sandra Russell, Email: sandrar@gene.com

This is a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that will enroll approximately 300 subjects. These subjects will be 12-75 years old with atopic asthma, have a history of asthma exacerbations, have elevated serum total IgE, have a baseline FEV1 ≥ 80% predicted, and be on inhaled corticosteroids with or without other controller asthma medications (e. g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).

Official title: A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Primary outcome: Average rate of asthma exacerbations

Secondary outcome:

Percentage of subjects experiencing one or more protocol-defined asthma exacerbations during the treatment period

Change from baseline in nocturnal and daytime asthma symptom scores

Change from baseline in pulmonary function as measured by FEV1 percent predicted

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a documented history of asthma as well as evidence of ≥ 12% reversibility of

FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol administration at any time during the preceding 24 months; 2) Documentation of ≥ 12% improvement in FEV1 with two separate measurements obtained within a 4-week period surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration of ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening

- Have screening FEV1 ≥ 80% predicted normal value

- Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro RAST(R)

or ImmunoCap(R) to one relevant perennial aeroallergen such as cat or house dust mites documented within the previous year

- Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder

inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to the screening visit

- Have had at least one asthma exacerbation requiring treatment with at least one course

of oral or intravenous corticosteroids or a doubling of the dose of inhaled corticosteroids for at least 3 days in the 12 months prior to screening despite being on a minimum of fluticasone DPI ≥ 200 ug/day or equivalent ex-valve dose

- During the 4-week run-in period prior to randomization, demonstrate evidence of

inadequate asthma symptom control despite inhaled corticosteroids with or without other controller asthma medications (e. g., LABA, LTRA, immunotherapy). Inadequate asthma symptom control is defined as at least one of the following reported on the subject diary card during the 4-week run-in period: Daytime asthma symptoms as a score of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as a day with no symptoms) and a mean symptom score of ≥ 1. 5 (mean will be calculated based on only data supplied; missing values will not be considered) or Nighttime awakening because of asthma symptoms (more than 4 times during the 4-week run-in period)

- Meet the study drug-dosing table eligibility criteria (serum baseline IgE level ≥ 30

to ≤ 1300 IU/mL and body weight ≥ 20 to ≤ 150 kg)

- If a female of childbearing potential, use an effective method of contraception (in

the opinion of the investigator) to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study

Exclusion Criteria:

- Have received chronic systemic corticosteroids (oral or intravenous) within 3 months

or have received a burst of oral corticosteroids within the last 2 weeks prior to screening

- Have received Xolair therapy at any time within 12 months prior to screening

- Are pregnant or lactating

- Have a known hypersensitivity to any ingredients of Xolair, including excipients

(sucrose, histidine, polysorbate 20)

- Have a lifetime history of smoking > 10-pack years

- Have active lung disease other than asthma (e. g., chronic bronchitis, emphysema,

cystic fibrosis, chronic obstructive pulmonary disease)

- Have a history of upper respiratory infection or lower respiratory infection within

the 30 days prior to randomization

- Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma

- Have taken immunosuppressants or other investigational drugs within the 30 days prior

to screening

- Have a significant medical illness other than asthma

Sandra Russell, Email: sandrar@gene.com

AL Allergy & Asthma Center, Birmingham, Alabama 35209, United States; Recruiting
Wendy Long, Phone: 205-871-9661, Email: wlong@alabamaallergy.com

Pediatric Care Medical Group, Huntington Beach, California 92647, United States; Recruiting
Patrice Jones, Phone: 714-842-1441, Ext: 241, Email: patricejones@pediatriccare.net

Clinical Research Specialists, Metairie, Louisiana 70006, United States; Recruiting
Michele Slattery, Phone: 504-885-2121, Email: crslats@aol.com

Midwest Allergy/Asthma Clinic, Omaha, Nebraska 68130, United States; Recruiting
Sheryl Leonard, Phone: 402-778-3622, Email: leonards@mwaac.com

Ocean Allergy & Resp Res Ctr, Brick, New Jersey 08724, United States; Recruiting
Sharon Eremita, Phone: 732-458-2000, Email: sniffleandsneeze@comcast.net

Pulmonary & Allergy Associates, Summit, New Jersey 07091, United States; Recruiting
Virginia Hala, Phone: 908-934-0440, Email: virginiah@paamds.com

ENT & Allergy Associates, Newburgh, New York 12550, United States; Recruiting
Catherine Parodo, Phone: 845-562-5794, Email: cparodo@entandallergy.com

Frederick C. Smith Clinic, Marion, Ohio 43302, United States; Recruiting
Sabine Stone, Phone: 740-383-7970

Asth & Allergy Research Assoc, Upland, Pennsylvania 19013, United States; Recruiting
Debra Kelly, Phone: 610-876-2103, Email: dekelly1231@aol.com

Allergy & Asthma Res Ctr PA, San Antonio, Texas 78229, United States; Recruiting
Patty Pompa-Aguilar, Phone: 210-616-0894, Email: jddiazmd@aol.com

Western Sky Medical Research, El Paso, Texas 79903, United States; Recruiting
Catherine Posey, Phone: 915-544-2557, Email: posey@westernskymed.com

Starting date: December 2005
Last updated: September 27, 2008