A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT01922037
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.

Study Details

This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

Key Dates

Start date
Jun 19, 2013
Status verified
Nov 2017
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
806 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants With Allergic Asthma
    Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.

Primary Outcome Measure

Total Number of Asthma Exacerbations During Months 1-12 [ Time Frame: Months 1-12 ]

Locations (145)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLCBirminghamAlabama35216-
Alabama Allergy & AsthmaBirminghamAlabama35209-
Huntsville Lung Associates PCHuntsvilleAlabama35801-
San Tan Allergy & AsthmaGilbertArizona85234-2966-
Dedicated Clinical ResearchGoodyearArizona85395-
Allergy Associates of TucsonTucsonArizona85716-
University of ArizonaTucsonArizona85724-5030-
Little Rock Allergy & Asthma; Clinical Research CenterLittle RockArkansas72205-
Stuart Epstein MD - PPBeverly HillsCalifornia90212-
West Coast Clinical Trials Global, LLCCosta MesaCalifornia92626-
Peninsula Allergy AssociatesDaly CityCalifornia94015-
Allianz Medical and Research CenterFountain ValleyCalifornia92708-
Gettysburg Medical ClinicFresnoCalifornia93726-
William Ebbeling MD - PPFresnoCalifornia93720-
Allergy & Asthma Inst ValleyGranada HillsCalifornia91344-
VA Loma Linda Healthcare SystemLoma LindaCalifornia92357-
Allergy Asthma Care Ctr, Inc.Los AngelesCalifornia90064-
Southern California Research CenterMission ViejoCalifornia92691-
North Bay Allergy & Asthma; Medical AssocNapaCalifornia94558-
Choc Psf, AmcOrangeCalifornia92868-
Clinical Trials of Orange CountyOrangeCalifornia92868-
California Allergy & Asthma Medical Group, Inc.PalmdaleCalifornia93551-
Joann Blessing-Moore MD - PPPalo AltoCalifornia94304-
TPMG - Rancho CordovaRancho CordovaCalifornia95762-
Redding Allergy & Asthma CareReddingCalifornia96003-
Allergy & Asthma ConsultantsRedwood CityCalifornia94063-
Capital Allergy Resp Dis CtrSacramentoCalifornia95819-
Central Coast Allergy and AsthmaSalinasCalifornia93901-
Allergy Assoc Medical GroupSan DiegoCalifornia92108-
Kaiser Permanente - San DiegoSan DiegoCalifornia92120-
Asthma & Allergy ClinicSan FranciscoCalifornia94121-
University of California at San FranciscoSan FranciscoCalifornia94115-
The Allergy and Asthma ClinicSan MateoCalifornia94401-
Allergy & Asthma Medical Group; Clinical Research DivisionWalnut CreekCalifornia94598-
IMMUNOe International Research CentersCentennialColorado80112-
Danbury HospitalDanburyConnecticut06810-
Christopher C Randolph MD - PPWaterburyConnecticut06708-
Waterbury Pulmonary AssociatesWaterburyConnecticut06708-
St. Francis Sleep; Allergy & Lung InstituteClearwaterFlorida33765-
AAADRS; Clinical Research CenterCoral GablesFlorida33134-
Allergy Asthma & Immun CenterLeesburgFlorida34788-
FL Ctr Allergy & Asthma ResMiamiFlorida33176-
Florida Ctr-Allergy & AsthmaMiamiFlorida33173-
Allergy & Asthma Care of FL; Clinical ResearchOcalaFlorida34471-
Central Florida Pulmonary GrouOrlandoFlorida32803-
Allergy Asthma & Sinus CenterPalm Beach GardensFlorida33410-
Gulf Coast Allergy Center, P.A.Port CharlotteFlorida33952-
USF Asthma Allergy & Immun; Clinical ResearchTampaFlorida33613-
Georgia PollensAlbanyGeorgia31707-
Brookstone Clinical Res CtrColumbusGeorgia31904-
Allergy & Asthma Care CenterGainesvilleGeorgia30501-
Aeroallergy Research LabsSavannahGeorgia31406-
Asthma & Allergy of IdahoTwin FallsIdaho83301-
Chest Medicine ConsultantsChicagoIllinois60657-
Rush University Medical CenterChicagoIllinois60612-
Allergy & Asthma Care LTDGlen CarbonIllinois62034-
Sneeze Wheeze and Itch Associates LLCNormalIllinois61761-
Allergy Asthma CareCrown PointIndiana46307-
The Allergy and Asthma CenterFort WayneIndiana46804-
Clinical Research Center of IndianaIndianapolisIndiana46208-
University of Kansas Med Ctr; Int med/Allgy/Immun/RheumKansas CityKansas66160-7350-
Kansas City Allergy And Asthma Assoc.Overland ParkKansas66210-
Abraham Research PLLCFlorenceKentucky41042-
Allergy & Asth Phys of Cent KYLexingtonKentucky40503-
Dr. Paul ShaperoBangorMaine04401-
Chesapeake Clinical Research Inc - CRNBaltimoreMaryland21236-
Glenn M. Silber, M.D., P.AEllicott CityMaryland21042-
Family Allergy & AsthmaGaithersburgMaryland20878-
Brigham and Women's HospitalBostonMassachusetts98410-
Center for Clinical Research.BrocktonMassachusetts02301-
Allergy Arth Fam Treatment CtrGardnerMassachusetts01440-
Infinity Medical Research IncNorth DartmouthMassachusetts02747-
McGovern & Baja Allergy AssocSpringfieldMassachusetts01103-
Asthma & Allergy Inst of MIClinton TownshipMichigan48038-
Asthma Allergy Ctr of SW MIPortageMichigan49024-
Clinical Research InstMinneapolisMinnesota55402-
Mayo ClinicRochesterMinnesota55905-
Washington Univ. School of MedSt LouisMissouri63141-
Impact Clinical TrialsLas VegasNevada89106-
Ocean Allergy & Resp Res CtrBrickNew Jersey08724-
Adult Ped Aller Central JerseyEdisonNew Jersey08820-
Center for Asthma and AllergyHighland ParkNew Jersey08904-
Atlantic Allergy Asthma Immunology AssociatesOcean CityNew Jersey07712-
Allergy Treatment Center of New JerseyPiscatawayNew Jersey08854-
Pulmonary and Allergy AssociatesSummitNew Jersey07901-
Allergy Consultants, PAVeronaNew Jersey07044-
Boris Sagalovich MD - PCBrooklynNew York11229-
SUNY Downstate Medical Center.BrooklynNew York11203-
Island Medical Research PcCommackNew York11725-
North Shore Medical Arts, LLPGreat NeckNew York11021-
Jamaica Hospital Medical CenterJamaicaNew York11418-
Winthrop Univ HospitalMineolaNew York11501-
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New YorkNew York10016-
Parikh Institute for Research LLCNew YorkNew York--
Albert P Hirdt DO - PPNewburghNew York12550-
Olean Medical GroupOleanNew York14760-
University of RochesterRochesterNew York14618-
Advanced Allergy & Asthma PLLCRockville CentreNew York11570-
Alan Kaufman MD - PPThe BronxNew York10465-
Montefiore Medical CenterThe BronxNew York10461-
Urban Health Plan, Inc.The BronxNew York10459-
Allergy Partners of Western NCAshevilleNorth Carolina28801-
Allergy & Asthma Centre of DaytonCentervilleOhio45458-
The Cleveland Clinic FoundationClevelandOhio44195-
Santiago Reyes MD-Private PracOklahoma CityOklahoma73112-
Vital Prospects Clin Res PcTulsaOklahoma74136-
Bend Memorial ClinicBendOregon97701-
Central PA Asth & Allergy Care; Research DivisionAltoonaPennsylvania16601-
Allergy and Asthmas; Specialists of HarrisburgHarrisburgPennsylvania17110-
Penn State Hershey Medical GroupHersheyPennsylvania17033-
Inst for Resp & Sleep Med PCLanghornePennsylvania19047-
Allergy and Asthma Research of NJ, lncPhiladelphiaPennsylvania19115-
Allergy & Clinical Immun AssocPittsburghPennsylvania15241-
South Hills Pulmonary AssocPittsburghPennsylvania15243-
Respiratory SpecialistsReadingPennsylvania19610-
Nat'l Aller Asth-CharlestonCharlestonSouth Carolina29406-
ADAC Research PAGreenvilleSouth Carolina29607-
Upstate Pharma ResearchSimpsonvilleSouth Carolina29681-
East Tennessee Center for Clinical ResearchKnoxvilleTennessee37909-
LeBonheur Children's HospitalMemphisTennessee38103-
Vanderbilt Medical UniversityNashvilleTennessee37203-
Greater Austin Allergy Asthma and ImmunologyAustinTexas78746-
Allergy Asthma Research AssocDallasTexas75231-
Elliot J. Ginchansky, MD, PADallasTexas75230-
University of Texas Medical Branch;Division of APICSGalvestonTexas77555-
Allergy Asthma & Immun AssocGarlandTexas75044-
Allergy & Asthma Res Ctr PASan AntonioTexas78251-
Live Oak Allergy & Asthma ClinicSan AntonioTexas78233-
Sugar Land Allerg Asthma ImmunSugar LandTexas77479-
University of Texas Health Center at TylerTylerTexas75708-
Allergy Associates of UtahMurrayUtah84107-
Bridgerland Clinical ResearchNorth LoganUtah84341-
Pulmonary Research of AlbingdonAbingdonVirginia24210-
O & O Alpan, LLCFairfaxVirginia22030-
Clinical Research Partners, LLCHenricoVirginia23233-
Allergy Asthma & Sinus CenterLeesburgVirginia20176-
Children's Hospital of the King's DaughterNorfolkVirginia23510-
Bellingham Asthma, Allergy & ImmunologyBellinghamWashington98225-
ASTHMA, IncSeattleWashington98105-
Pulmonary & Sleep ResearchSpokaneWashington99204-
Northwest Asthma Allergy CenterVancouverWashington98664-
Allergy Asthma & Sinus CenterGreenfieldWisconsin53228-
Dean ClinicMadisonWisconsin53715-
University of Wisconsin;Allergy & Asthma Clinical ResearchMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

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