Did you know that asthma is responsible for more than 500,000 hospital visits each year? Asthma can interfere with your child's daily activities. For children, asthma attacks are bothersome and can dramatically affect their ability to lead a normal, active life.
The purpose of this study is to determine the effectiveness of Xolair (omalizumab) in controlling moderate-severe allergic asthma in children 6-<12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and clinical measures. This drug is currently approved in the US for use by patients >12 years of age with allergic asthma. After an eight week run-in period, qualified participants will be assigned to study treatment or placebo for one year and a four month follow up. Certain visits will include a physical exam, medical history, breathing tests, blood draws, and questionnaires. All study related medication and testing is provided at no cost to you. Caregivers and children will need to attend 25-40 outpatient visits depending on the dose of study medication. You will be compensated for your time and travel.
Eligible participants:
- Male or female ages 6 – 12 years
- Asthma for at least one year
- Using asthma medications such as inhaled steroids
- Has had, in the past 2 years, an asthma attack requiring more medication or treatment in hospital or ER
- Qualifying body weight and IgE level
- Positive allergy test
Not eligible if:
- Previous Xolair treatment
Other criteria will be evaluated at screening.
If you would like information to learn how your child, or someone else you care about, can participate in this research program see the list below for a participating physician in your area.
Arkansas
Little Rock Allergy & Asthma Clinic (Little Rock, AR)
United States; Recruiting
Mindy DeMarco, 501-978-7147, mdemarco@littlerockallergy.com
Michelle Gray, 501-224-1156 ext. 157, kmgray@littlerockallergy.com
Principle Investigator: Karl Sitz, MD
California
West Coast Clinical Trials (Long Beach, CA)
United States; Recruiting
562-997-4078 x159
Ethel Cherri Parulan, cherrip@wcctrials.com
Lester Galan, lesterg@wcctrials.com
Principle Investigator: Kenneth Kim, MD
Children's Hospital of Orange County, Division of Asthma, Allergy & Immunology (Orange, CA)
United States; Recruiting
714-633-6363 x 3065
Elia Alvarez, ealvarez@choc.org
Brooke Bottrell-Hernandez, bhernandez@choc.org
Margarita Ramos, mramos@choc.org
Patricia Faiman, pfaiman@choc.org
Principle Investigator: Mark Ellis, MD
Allergy & Asthma Medical Group of Diablo Valley CR (Walnut Creek, CA)
United States; Recruiting
Mandy Surles, 925-935-2599, research@allergy-and-asthma.com
Principle Investigator: Nathan Schultz, MD
Bensch Research Associates (Stockton, CA)
United States; Recruiting
Sandy Vallery, 209-951-6741, sandyval@aol.com
Principle Investigator: George Bensch, MD
Joann Blessing-Moore, MD (Palo Alto, CA)
United States; Recruiting
Elisia Solomon, 650-688-8480/650-696-8236, elisiasolomon@hotmail.com
Principle Investigator: Joann Blessing-Moore, MD
Southern California Research Center (Mission Viejo, CA)
United States; Recruiting
Sherrye West, 949-347-8700 x219, swest@allergee.com
Sentelle Eubanks, 949-347-8700 x216, seubanks@allergee.com
Principle Investigator: William Berger, MD
Allergy and Asthma Associates of Santa Clara Valley RC (San Jose, CA)
408-553-0709 x231
Kathy Thomas, kathythomas@asthmaresearch.com
Michelle Robichaud, michelle@allergycare.com
Principle Investigator: Alan Goldsobel, MD
Roger Katz, MD (Santa Monica, CA)
United States; Recruiting
Silver Sender, MD, 310-393-1550, katzxolair@yahoo.com or rmcat@ucla.edu
Principle Investigator: Roger Katz, MD
California Allergy & Asthma Group (Palmdale, CA)
United States; Recruiting
Rose Warner, 661-266-8944, caamg@adelphia.net
Principle Investigator: Ricardo Tan, MD
Allergy Associates Medical Group (San Diego, CA)
United States; Recruiting
Donna Altmeyer, 619-229-2355 x330, daltmeyer@aaamg.com
Principle Investigator: Bruce Prenner, MD
Allergy and Asthma Specialists Medical Group (Huntington Beach, CA)
United States; Recruiting
Leslie Hamm, 714-848-8585 ext. 18, leslie@ocallergy.com
Principle Investigator: Steven Weinstein, MD
Capital Allergy & Respiratory Disease Clinic (Sacramento, CA)
United States; Recruiting
Eric Hanson, 916-457-8459, ehanson@capitalallergy.com
Principle Investigator: Bradley Chipps, MD
Allergy and Asthma Medical Group & Research Center (San Diego, CA)
United States; Recruiting
Susanne Brown, 858-268-2368 ext. 131, susannebrown@allergyandasthma.com
Principle Investigator: Nancy Ostrom, MD
Jacob Offenberger, MD (Granada Hills, CA)
United States; Recruiting
Carrie Rawding, 818-366-8112 x128, carrie@asthmadoc.com
Principle Investigator: Jacob Offenberger, MD
Pediatric Care and Medical Group (Huntington Beach, CA)
United States; Recruiting
Susan Marks, 714-842-1441 x231, research@pediatriccare.net or susanmarks@pediatriccare.net
Principle Investigator: Paul Qaqundah, MD
Integrated Research Group (Riverside, CA)
United States; Recruiting
Vanessa Rivera / Judy Kallman /Encarna Zamanian, MD, 951-781-7199, irgtrials@sbcglobal.net
Principle Investigator: Amit Patel, MD
Colorado
1st Allergy and Clinical Research Center (Centennial, CO)
United States; Recruiting
Simone Tafoya, 303-224-4672, s_tafoya@hotmail.com
Principle Investigator: Isaac Melamed, MD
National Jewish Medical and Research Center (Denver, CO)
United States; Recruiting
Kelli Brown, 303-398-1618, brownke@njc.org
Principle Investigator: Henry Milgrom, MD
Florida
Emerald Coast Clinical Research, LLC (Pensacola, FL)
United States; Recruiting
Frank Murphy/Renee Murphy, 850-969-2560, rmurphy@emeraldcoastclinicalresearch.org
Principle Investigator: Stephen Kimura, MD
Maria Franco, MD (Miami, FL)
United States; Recruiting
Hilda Santrock, 786-624-2833, hilda.santrock@mch.com
Principle Investigator: Maria Franco, MD
Georgia
Family Allergy and Asthma Center, PC (Atlanta, GA)
United States; Recruiting
Steve Goodman, 404-255-8080 ext. 1115, sgoodman@familyallergycenter.com
Principle Investigator: Robyn Levy, MD
AeroAllergy Research Laboratories of Savannah, Inc (Savannah, GA)
United States; Recruiting
Susie Kitchen, 912-356-3619, skitchen@coastalallergy.net
Principle Investigator: Brad Goodman, MD
Allergy and Asthma Clinics of Georgia (Albany, GA)
United States; Recruiting
Jonnie Owens, 229-883-8909, jowens@allergyclinicsofga.com
Principle Investigator: Tracy Bridges, MD
Illinois
Rush University Medical Center (Chicago, IL)
United States; Recruiting
Abbi Brees, 312-942-6296, abrees@rush.edu
Principle Investigator: James Moy, MD
Maryland
Glenn Silber, MD (Ellicott City, MD)
United States; Recruiting
Carrie Harris, 410-730-6000, carriesharris@comcast.net
Principle Investigator: Glenn Silber, MD
Minnesota
Asthma and Allergy Specialists (Plymouth, MN)
United States; Recruiting
763-744-1140, WHstudy@criminnesota.com
Barbara Deede, barbara.deede@criminnesota.com
Nan Hoerr, nan.hoerr@criminnesota.com
Principle Investigator: Alan Stillerman, MD
Nebraska
Midwest Allergy & Asthma Clinic (Omaha, NE)
United States; Recruiting
Sheryl Leonard, 402-397-7400, leonards@mwaac.com
Principle Investigator: Jeffrey Nelson, MD
Nevada
Allergy & Asthma Associates (Las Vegas, NV)
United States; Recruiting
Shawna Thomas, 702-432-9544 / 702-384-9101, allergyinlv@aol.com
Principle Investigator: David Tottori, MD
New Jersey
Ocean Allergy & Respiratory Research Center (Brick, NJ)
United States; Recruiting
Sharon Eremita, 732-458-2000 ext. 27, sniffleandsneeze@comcast.net
Principle Investigator: Bruce Decotiis, MD
New York
Asthma & Allergy Associates (Ithaca, NY)
United States; Recruiting
Ann Lawrence, 607-257-6563 / 607-753-9605, research@allergistdocs.com
Principle Investigator: Christopher Smith, MD
Island Medical Research (Allergy and Asthma Center) (Rockville Ctr., NY)
United States; Recruiting
Beth Erbe, 516-536-4863, imr242@optonline.net
Principle Investigator: Stanley Goldstein, MD
Jacobi Medical Center (Bronx, NY)
United States; Recruiting
718-918-6973
Cecilia Gutierrez, Cecilia.gutierrez@nbhn.net
Maria Chiodi, maria.chiodi@nbhn.net
Principle Investigator: Denise Serebrisky, MD
Maimonides Pediatric Pulmonology (Brooklyn, NY)
United States; Recruiting
Diana Kong, 718-377-0817 / 718-283-7339, DKong@maimonidesmed.org
Principle Investigator: Michael Marcus, MD
North Carolina
Allergy & Asthma Center of North Carolina (High Point, NC)
United States; Recruiting
Linda Wydysh, 336-883-1393, l.wydysh@northstate.net
Principle Investigator: Jose Bardelas, MD
Duke University Medical Center (Durham, NC)
United States; Recruiting
Ginny Dudek, 919-684-6534, dudek001@mc.duke.edu
Principle Investigator: Larry Williams, MD
Ohio
Bernstein Clinical Research Center (Cincinnati, OH)
United States; Recruiting
Karen Murphy, 513-931-0775, bernsteincrc@fuse.net
Principle Investigator: Jonathan Bernstein, MD
Oklahoma
Respiratory Diseases of Children and Adolescents (Oklahoma City, OK)
United States; Recruiting
Teresa Orf, 405-945-4495, sreyespedpulm@coxinet.net
Principle Investigator: Santiago Reyes, MD
Oregon
Clinical Research Institute of Southern Oregon (Medford, OR)
United States; Recruiting
541-494-3220
Heather Enenmann, hentenmann@criresearch.com
Dan Hamlin, dhamlin@criresearch.com
Principle Investigator: Edward Kerwin, MD
Allergy Asthma & Dermatology Research Center, LLC (Lake Oswego, OR)
United States; Recruiting
503-534-2622
Roxanne May, roxannemay@msn.com
Leaha Phillips, leahaphillips@aadrc.com
Elizabeth Forge, elizabethforge@aadrc.com
Principle Investigator: James Baker, MD
Rhode Island
AAPRI Clinical Research Institute (Providence, RI)
United States; Recruiting
Cheryl O'Neil, 401-751-1235, ashmamie@aol.com
Principle Investigator: John Zwetchkenbaum, MD
Tennesee
Vanderbilt University (Nashville, TN)
United States; Recruiting
Nan Frey, 615-936-5723 / 615-936-5764, nan.frey@vanderbilt.edu
Principle Investigator: David Hagaman, MD
Allergy Associates, The Allergy, Asthma & Sinus Center (Knoxville, TN)
United States; Recruiting
Jennifer Butcher/Wendy Hughes, 865-584-8588, jbutcher@allergyasc.com
Principle Investigator: Paul Carter, MD
Texas
Amarillo Ctr for Clinical Research (Amarillo, TX)
United States; Recruiting
Jacqueline Huntington, 806-352-2453, jacquieh@allergyarts.com
Principle Investigator: Constantine Saadeh, MD
Sugar Land Allergy, Asthma and Immunology Center, P.A. (Sugar Land, TX)
United States; Recruiting
Marsha Teuton, 281-494-4600, msanders@mylinuxisp.com
Principle Investigator: David Amran, MD
Allergy and Asthma Associates (Houston, TX)
United States; Recruiting
713-797-6716
Kara Turner, kturner@texallergy.com
Susan Muehe, smuehe@texallergy.com
Principle Investigator: Laura Somerville, MD
Pediatric Pulmonary Association of North Texas, PA (Dallas, TX)
United States; Recruiting
Diane Marshall, 972-566-5864,
Principle Investigator: Richard Silver, MD
Pediatric Allergy/Immunology Associates, PA (Dallas, TX)
United States; Recruiting
Carrie Miller / Rebecca Martin, 972-566-5473 / 972-566-7788, research_pdai@yahoo.com
Principle Investigator: Richard L. Wasserman, MD
Baylor College of Medicine, Texas Children Hospital (Houston, TX)
United States; Recruiting
Marcia Lima, MD, 832-824-1129, mlima@bcm.com
Principle Investigator: Stuart Abramson, MD
North Texas Institute for Clinical Trials (Fort Worth, TX)
United States; Recruiting
Diana Jones. 817-731-9198, diana.jones@ntict.com or debrantict@yahoo.com
Principle Investigator: Robert Lanier, MD
Sylvanna Research (San Antonio, TX)
United States; Recruiting
Shannon Syring, 210-614-6673, sylvanar@swbell.net
Principle Investigator: Paul Ratner, MD
Utah
Copperview Medical Center (South Jordan, UT)
United States; Recruiting
Thanh Nguyen, 801-984-2090, tnguyen@relia.net
Principle Investigator: Paul Shing-Jian Lei, MD
Virginia
Virginia Commonwealth University Medical Center (Richmond, VA)
United States; Recruiting
Tammy Anderson, 804-827-1856, tnanders@vcu.edu
Juel Gadd, 804-628-0212, jgadd@vcu.edu
Michelle M. Rhea, 804-682-1562, mmrhea@vcu.edu
Principle Investigator: Anne Marie Irani, MD
Children's Hospital of the Kings Daughters (CHKD) (Norfolk, VA)
United States; Recruiting
Mary Beth Donner, 757-554-5921, DonnerME@evms.edu
Principle Investigator: Cynthia Kelly, MD
Washington
A.S.T.H.M.A., Inc. (Seattle, WA)
United States; Recruiting
Laura Lee Steele, 206-525-5520, lsteele@asthmainc.org
Principle Investigator: Stephen Tilles, MD
Kerry Drain, MD (Spokane, WA)
United States; Recruiting
Michael Poffenroth, 509-624-8166 x 115, mpoffenroth@spokaneallergy.com
Principle Investigator: Kerry Drain, MD
Wisconsin
Medical College of Wisconsin (Milwaukee, WI)
United States; Recruiting
Meribeth Klancink, 414-266-6165, mklancni@mail.mcw.edu
Principle Investigator: Jordan Fink, MD
Dean Clinic Allergy & Asthma Research (Madison, WI)
United States; Recruiting
Leana L. Guelzow, 608-252-7406, leana.guelzow@deancare.com
Principle Investigator: Donald Bukstein, MD
