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Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma - Article


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General Topics A-Z

Asthma

Bronchial Asthma

Clinical Trial: Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma

This study is currently recruiting patients.

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals

Purpose

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab (Xolair®) is a new drug that inactivates IgE. This study will test the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Condition Treatment or Intervention Phase
Asthma
  Drug: Omalizumab
 Phase III

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: March 2004

This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Eligibility

Ages Eligible for Study:  6 Years   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

  • History of asthma attacks
  • Elevated IgE levels

Exclusion Criteria

  • History of severe allergy to food or drugs
  • Previous treatment with omalizumab(Xolair®)
  • Very low or high body weight

Other protocol-defined exclusion criteria may apply.


Location and Contact Information


Alabama
      Alabama Allergy and Asthma Center, Birmingham,  Alabama,  35209,  United States; Recruiting
Collette Cochran  205-871-9661 
Carol Smith, MD,  Principal Investigator

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72202,  United States; Recruiting
Karen Althage  501-364-3573    althegekarena@uams.edu 
Dr. Stacie Jones,  Principal Investigator

California
      Allergy and Asthma Associates of Santa Clara Valley RC, San Jose,  California,  95117,  United States; Recruiting
Kathy Thomas  408-553-0709  Ext. 231 
Dr. Alan Goldsobel,  Principal Investigator

      Allergy and Asthma Medical Group & Research Center, San Diego,  California,  92123,  United States; Recruiting
Susanne Brown  252-268-2368    aamgrc@aol.com 
Dr. Nancy Ostrom,  Principal Investigator

      Allergy Associates Medical Group, San Diego,  California,  92120,  United States; Recruiting
Donna Altmeyer  619-229-2355    daltmeyer@aaamg.com 
Dr. Bruce Prenner,  Principal Investigator

      Pediatric Care and Medical Group, Huntington Beach,  California,  92647,  United States; Recruiting
Susan Marks  714-842-1441  Ext. 238    research@pediatriccare.net 
Dr. Paul Quaqundah,  Principal Investigator

      Allergy & Asthma Med Group of Diablo Valley CR, Walnut Creek,  California,  94598,  United States; Recruiting
Debby Tate  925-935-2599    research@allergy-and-asthma.com 
Dr. Nathan Schultz,  Principal Investigator

      Allergy and Asthma Specialists Medical Group, Huntington Beach,  California,  92647,  United States; Recruiting
Leslie Hamm  714-848-8585    lhamm@aasmg.salu.net 
Dr. Steven Weinstein,  Principal Investigator

      Kaiser Permanente, San Diego,  California,  92111,  United States; Recruiting
Kathleen Harden  858-573-5404    Kathleen.m.harden@kp.org 
Robert Zieger, MD,  Principal Investigator

      Integrated Research Group, Riverside,  California,  92506,  United States; Recruiting
Sheina Santos  909-781-7199    irgtrials@sbcglobal.net 
Amit Patel, MD,  Principal Investigator

      Dr. Joann Blessing-Moore, Palo Alto,  California,  94304,  United States; Recruiting
Elisia Solomon  650-688-8480 
Joann Blessing-Moore, MD,  Principal Investigator

      Palo Alto,  California,  94304,  United States; Recruiting
Elisia Solomon  650 688 8480 
JoAnn Blessing-Moore, MD,  Principal Investigator

      Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology, Orange,  California,  92868,  United States; Recruiting
Brooke Allen  714-633-6363 
Mark Ellis, MD,  Principal Investigator

      West Coast Clinical Trials, Long Beach,  California,  90806,  United States; Recruiting
Lester Galan  562-997-8550 
Kenneth Kim, MD,  Principal Investigator

      CA Allergy & Asthma Med Group, Palmdale,  California,  93551,  United States; Recruiting
Rose Warner  661-266-8944 
Ricardo Tan, MD,  Principal Investigator

      Children's Hospital Los Angeles Allergy & Immunology, Los Angeles,  California,  90027,  United States; Recruiting
Theresa Dunaway  323-669-4537    tdunaway@chla.usc.edu 
Ronald Ferdman,  Principal Investigator

      Southern California Research Center, Mission Viejo,  California,  92691,  United States; Recruiting
Sherrye West  949-347-8700  Ext. 213 
William Berger,  Principal Investigator

      Bensch Research Associates, Stockton,  California,  95207,  United States; Recruiting
Sandy Vallery  209-951-6741    sandyval@aol.com 
George Bensch,  Principal Investigator

      Capital Allergy & Respiratory Disease Clinic, Sacramento,  California,  95819,  United States; Recruiting
Eric Hansen  916-457-8459    ericclintrial@aol.com 
Bradley Chipps,  Principal Investigator

Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States; Recruiting
Amber Shankles Pfister  303-398-1852    shanklesa@njc.org 
Dr. Henry Milgrom,  Principal Investigator

Florida
      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
Suyona Yun  305-668-5576 
Dr. Maria Franco,  Principal Investigator

      The Nemours Children's Clinic, Orlando,  Florida,  32806,  United States; Recruiting
Koleen Simpson  407-650-7165 
Dr. David Geller,  Principal Investigator

      Allergy and Asthma Care, Ocala,  Florida,  34471,  United States; Recruiting
Darby Seuss  352-629-2223    gcpstudies@aol.com 
Dr. Edward Stewart,  Principal Investigator

      University of Miami--Bachelor Children's Research Institute, Miami,  Florida,  33136,  United States; Recruiting
Samuel Gonzalez  305-243-6130 
Giovanni Piedmont, MD,  Principal Investigator

Georgia
      Allergy and Asthma Clinics of Georgia, Columbus,  Georgia,  31904,  United States; Recruiting
Debra Hale  229-883-8309    dhale@allergyclinicsofga.com 
Dr. Robert Chrzanowski,  Principal Investigator
Dr. Tracy Bridges,  Principal Investigator

      Family Allergy and Asthma Center, PC, Atlanta,  Georgia,  30342,  United States; Recruiting
Steve Goodman  404-255-8080    sgoodman@familyallergycenter.com 
Dr. Robyn Levy,  Principal Investigator

      Center for Allergy & Asthma, Carrollton,  Georgia,  30117,  United States; Recruiting
Jean Hollingsworth  770-836-7987    jhollingsworth@bellsouth.net 
Eugene Hurwitz, MD,  Principal Investigator

      Atlanta Center for Clinical Research, Woodstock,  Georgia,  30188,  United States; Recruiting
Mindy Spriggs  770-517-0250 
Jessenko Vukotic, MD,  Principal Investigator

      Allergy & Asthma Clinic of Northeast Georgia, Gainesville,  Georgia,  30501,  United States; Recruiting
Shannon Alleood  770-534-0534 
John Yarbrough, MD,  Principal Investigator

      Allergy & Asthma Clinics of Georgia, Albany,  Georgia,  31707,  United States; Recruiting
Debra Hale  229-883-8909    dhale@allergyclinicsofga.com 
Tracey Bridges, MD,  Principal Investigator

      Georgia Pollens, Albany,  Georgia,  31707,  United States; Recruiting
Debra Hale  229-883-8909 
Tracy Bridges, MD,  Principal Investigator

      Aeroallergy Research Labs of Savannah, Inc, Savannah,  Georgia,  31406,  United States; Recruiting
Susie Kitchen  912-356-3619 
Brad Goodman, MD,  Principal Investigator

      Center for Allergy & Asthma, Carrollton,  Georgia,  30117,  United States; Recruiting
Jean Hollingsworth  770-836-7987 
Eugene Hurwitz, MD,  Principal Investigator

      Northeast Georgia Research Center, Gainesville,  Georgia,  30501,  United States; Recruiting
Sharon Alleood  770-534-0534 
John Yarbrough, MD,  Principal Investigator

Illinois
      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Abbi Rees  312-942-6296    abress@rush.edu 
Dr. James Moy,  Principal Investigator

Indiana
      Riley Children's Hospital, Indianapolis,  Indiana,  46203,  United States; Recruiting
Delana Terrill  317-274-7205    dterrill@iupui.edu 
Dr. Frederick Leickly,  Principal Investigator

Louisiana
      AAI Asthma, Allergy, Immunology, Covington,  Louisiana,  70433,  United States; Recruiting
Marie Martinez  985-893-5780 
Richard Guillot, MD,  Principal Investigator

Maryland
      Dr. Glenn Silber, Elliott City,  Maryland,  21042,  United States; Recruiting
Carrie Harris  410-730-6000 

      Chesapeake Clinical Research, Baltimore,  Maryland,  21236,  United States; Recruiting
Renee Aparentado  410-931-1966 
Jonathan Matz, MD,  Principal Investigator

Massachusetts
      Northeast Med Research Associates, North Dartmouth,  Massachusetts,  02747,  United States; Recruiting
To Be Determined  508-992-7695 
Dr. David Miller,  Principal Investigator

Minnesota
      Children's Respiratory and Critical Care Specialists, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Christina Matthews Huebner  612-863-3226    huebner@crccs.com 
Dr. Michael Pryor,  Principal Investigator

      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
Kay Bachman  507-284-5689    bachman.kay@mayo.edu 
Dr. Gerald Volcheck,  Principal Investigator

Missouri
      St. Louis University School of Medicine, St. Louis,  Missouri,  63104,  United States; Recruiting
Geri Sanders  314-268-2700  Ext. 6021    geri_sanders@ssmhc.com 
Dr. Alan Knutsen,  Principal Investigator

      St. John's Medical Clinic, Springfield,  Missouri,  65807,  United States; Recruiting
Dayna Sweeney  417-820-2222 
Dr. Gregory Lux,  Principal Investigator

Nebraska
      Midwest Allergy & Asthma Clinic, Omaha,  Nebraska,  68114,  United States; Recruiting
Sherly Leonard  402-397-7400    leonards@mwaac.com 
Dr. M. Ross Thomas,  Principal Investigator

New York
      Island Medical Research (Allergy and Asthma Center), Rockville Center,  New York,  11570,  United States; Recruiting
Beth Erbe  516-536-4863 
Dr. Stanley Goldstein,  Principal Investigator

      Galisano Children's Hospital at Strong Div of Pediatric Pulm & Allergy, Rochester,  New York,  14642,  United States; Recruiting
Amy Kozlowski  585-275-8580    amy_kozlowski@urmc.rochester.edu 
Dr. Clement Ren,  Principal Investigator

      The Long Island College Hospital, Brooklyn,  New York,  11201,  United States; Recruiting
Miriam Klein  718-780-4675 
Bernard Silverman, MD,  Principal Investigator

      Children’s Medical Group, Poughkeepsie,  New York,  12603,  United States; Recruiting
Michael Lerner  845-452-1704    Mlerner@childrensmedgroup.com 
Herschel Lessin, MD,  Principal Investigator

      The Children’s Medical Group, PLLC, Poughkeepsie,  New York,  12603,  United States; Recruiting
Michael Lerner  845-452-1704 
Herschel Lessin, MD,  Principal Investigator

      Long Island College Hospital--Allergy & Immunology Dept., Brooklyn,  New York,  11201,  United States; Recruiting
Miriam Klein  718-780-4675 
Bernard Silverman, MD,  Principal Investigator

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ginny Dudek  919-684-6534    dudek001@mc.duke.edu 
Dr. Larry Williams,  Principal Investigator

Ohio
      Columbus Childrens, The Ohio State University, Columbus,  Ohio,  43205,  United States; Recruiting
Melissa Joseph  614-722-4767 
Dr. Richard Shell,  Principal Investigator

      Bernstein Clinical Research Center, Cincinnati,  Ohio,  45231,  United States; Recruiting
Karen Murphy  513-931-0775  Ext. 114 
Jonathan Bernstein, MD,  Principal Investigator

      Bernstein Clinical Research, Cincinatti,  Ohio,  45231,  United States; Recruiting
Karen Murphy  513-931-0775 
Jonathan Bernstein, MD,  Principal Investigator

Pennsylvania
      Hershey Medical Ctr Allergy Clinic & Asthma Research, Hershey,  Pennsylvania,  17033-2360,  United States; Recruiting
Cathy Mende  717-531-4513 
Dr. Timothy Craig,  Principal Investigator

      West Penn Allegheny General Health System, Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
Betty Angelini  412-359-6642    bangelin@wpahs.org 
Dr. David Skoner,  Principal Investigator

      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
To Be Determined  215-590-2549 
Dr. Jonathan Spergel,  Principal Investigator

Rhode Island
      Allergy & Asthma Center, Providence,  Rhode Island,  02906,  United States; Recruiting
Roberta Vierra  401-331-7234    allergyasthmaresearch@yahoo.com 
Dr. Robert Settipane,  Principal Investigator

      AAPRI Clinical Research Institute, Lincoln,  Rhode Island,  02865,  United States; Recruiting
Cheryl O'Neil  401-334-0410 
John Zwetchkenbaum, MD,  Principal Investigator

      AAPRI Clinical Research Institute, Lincoln,  Rhode Island,  02865,  United States; Recruiting
Cheryl O'Neil  401-334-0410 
John Zwetchkenbaum, MD,  Principal Investigator

Tennessee
      Vanderbilt University, Nashville,  Tennessee,  37203,  United States; Recruiting
Lisa Gentry  615-936-5764    lisa.gentry@vanderbilt.edu 
Dr. John Murray,  Principal Investigator

Texas
      North Texas Institute for Clinical Trials, Ft. Worth,  Texas,  76132,  United States; Recruiting
Diane Jones  817-731-9198    cdjoneslearn@yahoo.com 
Dr. Bobby Lanier,  Principal Investigator

      UTHSC-Houston, Houston,  Texas,  77030,  United States; Recruiting
Evelyn Henninger  713-500-5108    Evelyn.D.Henninger@uth.tmc.edu 
Dr. Gailen Marshall,  Principal Investigator

      Pediatric Allergy/Immunology Associates, PA, Dallas,  Texas,  75230,  United States; Recruiting
Rebecca Martin  972-566-7788    research_pdai@yahoo.com 
Dr. John Meiser,  Principal Investigator

      Sylvanna Research, San Antonio,  Texas,  78229,  United States; Recruiting
Shannon Syring  210-614-6673    sylvanar@swbell.net 
Dr. Paul Ratner,  Principal Investigator

      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Chivon Jackson  832-824-1129 
Stuart Abramson, MD,  Principal Investigator

      Allergy & Asthma Center of El Paso, El Paso,  Texas,  79925,  United States; Recruiting
Marie Ross  915-591-2080 
Rodger Menedez, MD,  Principal Investigator

      Pediatric Pulmonary Association of North Texas, Dallas,  Texas,  75230,  United States; Recruiting
Michelle Bastides  972-566-5864 
Richard Silver, MD,  Principal Investigator

Utah
      Copperview Medical Center, South Jordan,  Utah,  84095,  United States; Recruiting
Ivana Shearer  801-984-2090 
Paul Shing-Jian Lei, MD,  Principal Investigator

      Copperview Medical Ct, South Jordan,  Utah,  84095,  United States; Recruiting
Rachel Moore  801-984-2090 
Paul Shing-Jian Lei, MD,  Principal Investigator

Washington
      A.S.T.H.M.A., Inc., Seattle,  Washington,  98105,  United States; Recruiting
Laurel Lee  206-525-5520 
Dr. Stephen Tilles,  Principal Investigator

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Mary Beth Klancink  414-266-6165    mklancni@mcw.edu 
Dr. Kevin Kelly,  Principal Investigator

More Information

Novartis Study IA05 web site

http://www.pediatricasthmastudy.com

Study ID Numbers:  CIGE025AIA05
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  March 18, 2004
ClinicalTrials.gov Identifier:  NCT00079937
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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