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NCT06977581RecruitingPhase 2

A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ASTHMA

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 18 to 75 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 6 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants will be involved in this study for up to approximately 9.5 months depending on local requirements.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
252 (estimated)
First submitted
25 Apr 2025
Start date
20 May 2025
Primary completion date
8 Mar 2027
Lead sponsor
Pfizer
Diseases
Asthma
NCT number
NCT06977581
EU CT number
2024-517866-40-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 252
  • From 20 May 2025 to the primary completion date, 8 Mar 2027
  • 138 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Diagnosed with any of the following acute or chronic infections or infection history:
    • Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;
    • Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
    • Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1.
    • Prior/Concomitant Therapy:
  • Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
  • Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4, IL-13, IL-33/ST2, IL-4Rα, TSLP, IL-5, OX40/OX40L or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.
  • Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
  • Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
  • Bronchial thermoplasty within the previous 24 months.
    • Prior/Concurrent Clinical Study Experience:
  • Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Other illness

  • Medical Conditions:
  • Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis
  • History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.

Lab values

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Who the study is looking for

  • Must meet the following asthma criteria:
  • History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
  • Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 24 months of the screening visit.
  • At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to \<80% of predicted normal values.
  • Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
  • Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
  • ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
    • Other Inclusion Criteria:
  • Body mass index between 18 -40 kg/m2 at screening.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (138)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaRecruiting
Fundacion Cidea
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Buenos AiresArgentinaRecruiting
Fundacion Respirar
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Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Instituto Ave Pulmo
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Mar del PlataArgentinaRecruiting
Fundacion Scherbovsky
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MendozaArgentinaRecruiting
Instituto de Salud Respiratoria
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MendozaArgentinaRecruiting
Instituto Especialidades de la Salud Rosario
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RosarioArgentinaRecruiting
Investigaciones en Patologias Respiratorias
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San Miguel de TucumánArgentinaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
A.Z. Sint-Maarten
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MechelenBelgiumRecruiting
Medical Center Pulmo - 2018 EOOD
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HaskovoBulgariaRecruiting
Medical Center Pulmovision Ltd.
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SofiaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
Medical Center New Rehabilitation Center EOOD
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Stara ZagoraBulgariaRecruiting
The First Affiliated Hospital of Baotou Medical College
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BaotouChinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Beijing Chao-Yang Hospital, Capital Medical University
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BeijingChinaRecruiting
The Second Hospital of Jilin University
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ChangchunChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The Third Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Zhejiang Provincial People's Hospital
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HangzhouChinaRecruiting
The First People's Hospital of Hangzhou
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HangzhouChinaRecruiting
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaRecruiting
Inner Mongolia People's Hospital
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HohhotChinaRecruiting
Nanjing First Hospital
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NajingChinaRecruiting
Jiangxi Provincial People's Hospital
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NanchangChinaRecruiting
Jiangsu Province Hospital
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NanjingChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai General Hospital
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ShanghaiChinaRecruiting
Shanghai Pulmonary Hospital
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ShanghaiChinaRecruiting
Taizhou Central Hospital
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TaizhouChinaRecruiting
The First Affiliated Hospital of Xi'an Medical University
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Xi'anChinaRecruiting
The Affiliated Hospital of Xuzhou Medical College
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XuzhouChinaRecruiting
Xuzhou Central Hospital
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XuzhouChinaRecruiting
Mudr.I.Cierna Peterova s.r.o.
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Brandýs nad LabemCzechiaRecruiting
MUDr.I. Cierna Peterova s.r.o.
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Brandýs nad Labem-Stará BoleslavCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
MEDITRIAL s.r.o.
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Jindrichuv Hradec IIICzechiaRecruiting
CEFISPIRO s.r.o.
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LovosiceCzechiaRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Bradford Royal Infirmary
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BradfordUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Outpatients
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CambridgeUnited KingdomRecruiting
North Manchester General Hospital
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CrumpsallUnited KingdomRecruiting
Hammersmith Hospital
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LondonUnited KingdomRecruiting
Wythenshawe Hospital
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ManchesterUnited KingdomRecruiting
Pinderfields General Hospital
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WakefieldUnited KingdomRecruiting
Edelenyi Koch Robert Korhaz es Rendelointezet
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EdelényHungaryRecruiting
Erzsebet Gondozohaz Kft.
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GödöllőHungaryRecruiting
Szalay János Rendelőintézet
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HajdúnánásHungaryRecruiting
Omnimodus Elixír Kft.
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MosonmagyaróvárHungaryRecruiting
Da Vinci Spa Kft.
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PecsHungaryRecruiting
Azienda Ospedaliero-Universitaria Di Cagliari
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MonserratoItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyRecruiting
IRCCS Humanitas Research Hospital
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Rozzano MIItalyRecruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyRecruiting
Azienda Ospedaliero Universitaria Senese
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SienaItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyRecruiting
Mazda Hospital
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Aki-gun Fuchu-choJapanRecruiting
Fukuwa Clinic
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Chuo-kuJapanRecruiting
Fujieda Municipal General Hospital
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FujiedaJapanRecruiting
Fukuoka National Hospital
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FukuokaJapanRecruiting
Tokyo Medical University Hachioji Medical Center
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HachiōjiJapanRecruiting
Hamamatsu Rosai Hospital
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HamamatsuJapanRecruiting
Hiroshima Prefectural Hospital
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HiroshimaJapanRecruiting
National Hospital Organization Osaka Minami Medical Center
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Kawachi-NaganoJapanRecruiting
Kobe City Medical Center West Hospital
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KobeJapanRecruiting
NHO Kinki-Chuo Chest Medical Center
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SakaiJapanRecruiting
Yeungnam Univeristy Medical Center
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DaeguSouth KoreaRecruiting
Yeungnam University Hospital
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DaeguSouth KoreaRecruiting
jeonbuk National University Hospital
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JeonjuSouth KoreaRecruiting
Konkuk University Medical Center
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaRecruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaTerminated
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
KLIMED Marek Klimkiewicz
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BychawaPolandRecruiting
Malopolskie Centrum Alergologii Sp. z o.o.
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CracowPolandRecruiting
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
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PoznanPolandRecruiting
Alergologia Plus sp. z o.o.
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PoznanPolandRecruiting
PULMAG Grzegorz Gasior Marzena Kociolek S.C.
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SosnowiecPolandRecruiting
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
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TarnówPolandRecruiting
Dobrostan Gabinety Lekarskie
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Wroc?awPolandRecruiting
Changhua Christian Hospital
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Changhua CountyTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Far Eastern Memorial Hospital
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New Taipei CityTaiwanRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanRecruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
North Ingalls Building
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Ann ArborUnited StatesRecruiting
South Texas Medical Research Institute, Inc., DBA TTS Research
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BoerneUnited StatesRecruiting
Christie Clinic - Windsor
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ChampaignUnited StatesRecruiting
Innovo Research - Christie Clinic
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ChampaignUnited StatesRecruiting
Christie Clinic - University
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ChampaignUnited StatesRecruiting
Chandler Clinical Trials
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ChandlerUnited StatesRecruiting
American Health Research
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CharlotteUnited StatesRecruiting
Colorado ENT & Allergy
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Colorado SpringsUnited StatesRecruiting
Horizon Clinical Research Group
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CypressUnited StatesRecruiting
Alina Clinical Trials, LLC.
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DallasUnited StatesRecruiting
Clinical Research Associates of Central Pa, LLC
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DuBoisUnited StatesRecruiting
Cpcc-Research Llc
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East PointUnited StatesRecruiting
OK Clinical Research
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EdmondUnited StatesRecruiting
Clinical Research of Gastonia
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GastoniaUnited StatesRecruiting
Henderson Clinical Trials
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HendersonUnited StatesRecruiting
Premier Research Center, LLC
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HendersonvilleUnited StatesRecruiting
Greater Heights Memorial Pulmonary and Sleep
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HoustonUnited StatesRecruiting
Houston Pulmonary Sleep and Allergy Associates
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HoustonUnited StatesRecruiting
Stern Research Partners, LLC
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HuntersvilleUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Antelope Valley Clinical Trials
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LancasterUnited StatesRecruiting
Metroplex Pulmonary and Sleep Center
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McKinneyUnited StatesActive, not recruiting
Velocity Clinical Research, Mobile
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MobileUnited StatesRecruiting
Rutgers, Robert Wood Johnson Medical School
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New BrunswickUnited StatesRecruiting
NewportNativeMD, Inc.
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Newport BeachUnited StatesRecruiting
California Medical Research Associates
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NorthridgeUnited StatesRecruiting
Allergy, Asthma and Clinical Research
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Oklahoma CityUnited StatesRecruiting
Clinical Research Partners, LLC
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RichmondUnited StatesRecruiting
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
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RiverdaleUnited StatesRecruiting
Clinical Research of Rock Hill
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Rock HillUnited StatesRecruiting
Allergy and Asthma Associates of Santa Clara Valley Research Center
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San JoseUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Toledo Institute of Clinical Research Inc.
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ToledoUnited StatesRecruiting
Layrek Clinical Research
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TulsaUnited StatesRecruiting
Allergy & Asthma Clinical Research
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Walnut CreekUnited StatesRecruiting
Durban International Clinical Research Site, Enhancing Care Foundation
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DurbanSouth AfricaRecruiting
Synapta Clinical Research Centre
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DurbanSouth AfricaRecruiting
St. Augustine's Medical Centre 2
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DurbanSouth AfricaRecruiting
WITS Clinical Research
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JohannesbergSouth AfricaRecruiting
Wits Clinical Research
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JohannesburgSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.