Clinical trial NCT04682639: A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic esophagitis
Esophageal eosinophilia
Etrasimod
APD334
EoE
Eosinophilic oesophagitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2020-12-24
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.


Eligibility criteria: Inclusion Criteria:

* Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)
* Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period

Inclusion Criteria for the Extension Treatment Period

* Completion of the Week 24 study visit \[including esophagogastroduodenoscopy (EGD)\]
* Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
* No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
* Willing to comply with all study visits and procedures for the Extension Treatment Period

Exclusion Criteria:

* History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
* Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
* Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
* Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:

  1. Elemental diet
  2. EoE food trigger elimination diet
  3. Proton pump inhibitor (PPI) therapy
* Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
* Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
* Use of any investigational agent or device within 12 weeks prior to Baseline
* Females who are pregnant

Primary outcomes:
measure: Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
timeFrame: Week 16
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Maximum Severity During 24 Week Double Blind Treatment Period
timeFrame: Baseline, up to Week 24
measure: Number of Participants With Serious TEAEs, TEAEs Leading to Study Treatment Discontinuation, TEAEs Leading to Death and TEAEs of Special Interest During 24 Week Double Blind Treatment Period
timeFrame: Baseline up to Week 24
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Birmingham
country: United States
facility: GastroHealth - St. Vincent's East
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Dothan
country: United States
facility: Dothan Eyecare - Dr. Brent McKinley (OCT Procedure Only)
state: Alabama
city: Dothan
country: United States
facility: Dothan Surgery Center (Colonoscopy Location)
state: Alabama
city: Dothan
country: United States
facility: Pulmonary Associates (PFT Procedure Only, Second Location )
state: Alabama
city: Dothan
country: United States
facility: Flowers Hospital (PFT Procedure Only)
state: Alabama
city: Huntsville
country: United States
facility: Avant Research Associates, LLC
state: Alabama
city: Huntsville
country: United States
facility: Crestwood Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Baily Cove Eye Care
state: Alabama
city: Madison
country: United States
facility: Madison Surgery Center
state: Alabama
city: Vestavia Hills
country: United States
facility: Alabama Eye MD
state: Alabama
city: Peoria
country: United States
facility: Arizona Retina Institute/ Phoenix Retina Associates(OCT)
state: Arizona
city: Peoria
country: United States
facility: SimonMed Imaging (Imaging)
state: Arizona
city: Sun City
country: United States
facility: Arizona Digestive Health - Sun City
state: Arizona
city: Sun City
country: United States
facility: Sun City Endoscopy Center (Endoscopy)
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Eye Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Four Seasons Allergy and Asthma
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Premier Gastroenterology Endoscopy Center
state: Arkansas
city: Little Rock
country: United States
facility: Premier Gastroenterology
state: Arkansas
city: Fountain Valley
country: United States
facility: Isight Vision Care
state: California
city: Fountain Valley
country: United States
facility: Mile Square Surgery Center
state: California
city: Fountain Valley
country: United States
facility: Pulmonary & Sleep Consultants
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical, Inc.
state: California
city: Lake Elsinore
country: United States
facility: Inland Pulmonary Specialists [PFT Only]
state: California
city: Lancaster
country: United States
facility: Advanced Endoscopy and Pain Center - EGD & Biopsy Collection
state: California
city: Lancaster
country: United States
facility: Advanced Endoscopy and Pain Center
state: California
city: Lancaster
country: United States
facility: Antelope Valley Eye Care - OCT
state: California
city: Lancaster
country: United States
facility: Antelope Valley Eye Care
state: California
city: Lancaster
country: United States
facility: Antelope Valley Lung and Sleep Institute
state: California
city: Lancaster
country: United States
facility: Apollo Surgery Center
state: California
city: Lancaster
country: United States
facility: AV Pediatrics, Allergy and Family Medicine - PFT, Physical Exams, Lab Reviews, ECG Reviews
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Lancaster
country: United States
facility: Jatinder S. Pruthi, MD FACG CPI - Physical Exams, Lab Reviews, ECG Reviews
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: Clinical Trials Unit
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care (OCT)
state: California
city: Murrieta
country: United States
facility: United Surgery Center Murrieta [Endoscopy Only]
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Temecula
country: United States
facility: California Eye Professionals [OCT Only]
state: California
city: Temecula
country: United States
facility: United Surgery Center Temecula [Endoscopy Only]
state: California
city: Boynton Beach
country: United States
facility: RecioMed Clinical Research Network, Inc
state: Florida
city: Bradenton
country: United States
facility: Steelgate
state: Florida
city: Clearwater
country: United States
facility: Bay Area Chest Physicians, P.A., - Pulmonary Function Test
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy Center
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy
state: Florida
city: Clearwater
country: United States
facility: MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)
state: Florida
city: Clearwater
country: United States
facility: Northwood Vision Optical Coherence Tomography (OCT)
state: Florida
city: Clearwater
country: United States
facility: Safety Harbor Surgery Center
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida (Regulatory & Administrative Duties)
state: Florida
city: Coral Gables
country: United States
facility: Beraja Medical Institute (OCT)
state: Florida
city: Crystal River
country: United States
facility: Bayfront Health Seven Rivers (Liver Biopsy Location)
state: Florida
city: Crystal River
country: United States
facility: Citrus Surgery and Endoscopy Center (EGD Location)
state: Florida
city: Hialeah
country: United States
facility: Advanced Eye Center
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: West Coast Eye Institute (OCT Procedure Only)
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center (EGD Location)
state: Florida
city: Jupiter
country: United States
facility: Jupiter Outpatient Surgery Center
state: Florida
city: Lakeland
country: United States
facility: Central Florida Sleep Diagnostic & Treatment Center
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research
state: Florida
city: Lecanto
country: United States
facility: West Coast Eye Institute (OCT Procedure Only)
state: Florida
city: Miami
country: United States
facility: The Endoscopy Center (Endoscopy Procedure)
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: Juan Barrio, MD (PFT when needed)
state: Florida
city: Riverview
country: United States
facility: Florida Eye Specialists and Cataract Institute
state: Florida
city: Sebring
country: United States
facility: Dr. Dennis Bassetti, MD
state: Florida
city: Sebring
country: United States
facility: Highlands Eye Institute, P.A.
state: Florida
city: Sebring
country: United States
facility: The Surgery and Endoscopy Center
state: Florida
city: Tampa
country: United States
facility: Ambulatory Surgery Center
state: Florida
city: Tampa
country: United States
facility: Pulmonology & Sleep Disorders
state: Florida
city: Winter Haven
country: United States
facility: Day Surgery Center
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Allergy and Asthma Clinica - Pulmonary Function Test
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital- DLCO
state: Georgia
city: Atlanta
country: United States
facility: Ross Eyecare - Opthalmoscopy and OCT
state: Georgia
city: Decatur
country: United States
facility: Georgia Eye Partners
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Decatur
country: United States
facility: Atlanta Endoscopy Center LTD
state: Georgia
city: Decatur
country: United States
facility: Pulmonary & Sleep Specialist
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Idaho Falls
country: United States
facility: Grand Teton Surgical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Idaho Falls Pulmonary/ Sleep and Critical Care Specialists (PFT procedure only)
state: Idaho
city: Idaho Falls
country: United States
facility: Premier Eye Care of Eastern Idaho (OCT procedure only)
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Glenview
country: United States
facility: Glen Endoscopy Center (Endoscopy Facility)
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance (PFT)
state: Illinois
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
state: Illinois
city: Gurnee
country: United States
facility: Medical Eye Services LTD (Ophthalmoscopy with OCT)
state: Illinois
city: Lake Bluff
country: United States
facility: North Shore Endoscopy Center (Endoscopy)
state: Illinois
city: Libertyville
country: United States
facility: Libertyville Imaging Center (Diagnostic Imaging)
state: Illinois
city: Jeffersonville
country: United States
facility: Clark Memorial Health (PFTs)
state: Indiana
city: Jeffersonville
country: United States
facility: One Anesthesia, AACC Division
state: Indiana
city: New Albany
country: United States
facility: Baptist Health Floyd (PFTs)
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology Health Partners, PLLC, (IP)
state: Indiana
city: New Albany
country: United States
facility: John Kenyon Eye Center (OCT)
state: Indiana
city: New Albany
country: United States
facility: One Anesthesia, PLLC
state: Indiana
city: New Albany
country: United States
facility: Physicians Medical Center (Endoscopies)
state: Indiana
city: Lenexa
country: United States
facility: Quest
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinic (OCT Procedure Only)
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinic (PFT Procedure Only)
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Lafayette
country: United States
facility: Acadiana Endoscopy Center, Inc
state: Louisiana
city: Lafayette
country: United States
facility: Acadiana Gastroenterology Associates
state: Louisiana
city: Lafayette
country: United States
facility: Combined Gastro Research, LLC
state: Louisiana
city: Lafayette
country: United States
facility: Gastroenterology Clinic of Acadiana (IP address)
state: Louisiana
city: Lafayette
country: United States
facility: Lafayette General Endoscopy Center
state: Louisiana
city: Lafayette
country: United States
facility: Lafayette Family Eye Care
state: Louisiana
city: Minneapolis
country: United States
facility: M Health Fairview Clinics and Surgery Center
state: Minnesota
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Health Clinical research unit
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Health Opthalmology Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lincoln
country: United States
facility: Celerion, Inc.
state: Nebraska
city: Brick
country: United States
facility: Del Negro & Senft Eye Associates
state: New Jersey
city: Brick
country: United States
facility: Allied Health Clinical Research Organization, LLC (IP Address)
state: New Jersey
city: Brick
country: United States
facility: Seashore Surgical Institute
state: New Jersey
city: Brick
country: United States
facility: Shore Pulmonary, PA
state: New Jersey
city: Freehold
country: United States
facility: Allied Health Clinical Research Organization, LLC
state: New Jersey
city: Neptune
country: United States
facility: Del Negro & Senft Eye associates
state: New Jersey
city: Red Bank
country: United States
facility: Del Negro & Senft eye Associates
state: New Jersey
city: Chapel Hill
country: United States
facility: lnvestigational Drug Services, University of North Carolina Hospitals (IP storage address)
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Clinical Research Eastowne
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals Pulmonary Function Lab (PFT and DLCO procedures only)
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina - Memorial Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Endoscopy Center at Meadowmont
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals Pulmonary Specialty Clinic (PFT and DLCO procedures only)
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center (OCT procedure only)
state: North Carolina
city: Chapel Hill
country: United States
facility: Clinical and Translational Research Center Outpatient Unit
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Plaza North Duke Street
state: North Carolina
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Investigational Drug Services (Pharmacy)
state: North Carolina
city: Fayetteville
country: United States
facility: Coastal Research Institute
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Hillsborough
country: United States
facility: UNC Gastroenterology at Hillsborough
state: North Carolina
city: Raleigh
country: United States
facility: Brier Creek Medical Pavilion
state: North Carolina
city: Chardon
country: United States
facility: Geauga Sleep Center (PFT Only)
state: Ohio
city: Cincinnati
country: United States
facility: Leon A. Reid, III, M.D. (OCT)
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute (ophthalmic and OCT exams)
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
city: Cincinnati
country: United States
facility: Ohio GI and Liver Institute
state: Ohio
city: Cincinnati
country: United States
facility: Tristate Endoscopy Center (Endoscopy)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Hoxworth (ophthalmic and OCT only)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Physicians Office Clifton (where subjects seen)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Pulmonary (PFT Location)
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center Diagnostic Center (Endoscopy location)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Pulmonary (Pulmonary Function Testing)
state: Ohio
city: Cincinnati
country: United States
facility: Leon A. Reid, III, M.D. (OCT)
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research (PFT)
state: Ohio
city: Cincinnati
country: United States
facility: University Endoscopy Center (Endoscopy location)
state: Ohio
city: Cincinnati
country: United States
facility: UC Health/Division of Digestive Diseases (where subjects seen)
state: Ohio
city: Columbus
country: United States
facility: Erdey Searcy Eye Group
state: Ohio
city: Dublin
country: United States
facility: Ohio Gastroenterology Group
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Medical Research, LLC
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Painesville
country: United States
facility: Vitreo Retinal Consultants (OCT only)
state: Ohio
city: Willoughby Hills
country: United States
facility: Retina Specialists of Ohio(OCT only)
state: Ohio
city: Willoughby
country: United States
facility: Lake Pulmonary Associates (PFT only)
state: Ohio
city: Norman
country: United States
facility: Norman Endoscopy Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc. Endoscopy Lab
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pulmonary Physicians of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Retinal Center of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Johnston Eye
state: Oklahoma
city: Camp Hill
country: United States
facility: West Shore Endoscopy Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Medical Arts Allergy,PC (PFT Only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Farrel Opthalmology(OCT only)
state: Pennsylvania
city: Harrisburg
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Eye Associates (OCT only)
state: Pennsylvania
city: Lemoyne
country: United States
facility: Penn State Health Medical Group - Lemoyne (PFT only)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Drug Services
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: West Reading
country: United States
facility: Tower Health Reading Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Center for Digestive Health
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists "PFT Procedure Only"
state: Pennsylvania
city: Wyomissing
country: United States
facility: Eye Consultants of Pennsylvania, PC "OCT Procedure Only"
state: Pennsylvania
city: Wyomissing
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Medical Center, LLP
state: South Dakota
city: Johnson City
country: United States
facility: Franklin Woods Community Hospital (PFT Only)
state: Tennessee
city: Johnson City
country: United States
facility: Pulmonary Associates of ET/Jeff Farrow, MD - PFT only
state: Tennessee
city: Kingsport
country: United States
facility: The Regional Eye Center - OCT only
state: Tennessee
city: Kingsport
country: United States
facility: Tri-Cities Gastroenterology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt GI Endoscopy Lab at One Hundred Oaks
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - GI Research Office
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center GI Endoscopy Lab
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Pulmonary Medicine
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Digestive Disease Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Heart Station
state: Tennessee
city: Dallas
country: United States
facility: Digestive Health Center (Endoscopy)
state: Texas
city: Houston
country: United States
facility: Precision for Medicine
state: Texas
city: New Braunfels
country: United States
facility: CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center-new Braunfels(Endoscopy)
state: Texas
city: New Braunfels
country: United States
facility: Tyrus Schroeder (PFT)
state: Texas
city: Plano
country: United States
facility: The Eye Place Jenny Fan, OD (OCT Only)
state: Texas
city: Richardson
country: United States
facility: Pulmonary Medicine Consultants (PFT with DCLO only)
state: Texas
city: San Marcos
country: United States
facility: Advanced Imaging
state: Texas
city: San Marcos
country: United States
facility: Central Texas Eye Center (OCT)
state: Texas
city: San Marcos
country: United States
facility: CHRJSTUS Santa Rosa Physicians Ambulatory Surgery Center - San Marcos (Endoscopy)
state: Texas
city: Webster
country: United States
facility: Bay Area Houston Endoscopy Center (Endoscopy)
state: Texas
city: Webster
country: United States
facility: Coastal Eye Associates (OCT)
state: Texas
city: Webster
country: United States
facility: GI Alliance (Patients Seen)
state: Texas
city: Webster
country: United States
facility: Houston Lung and Sleep Clinic, PA (PFT)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Gastroenterology Division Research
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University Of Utah School Of Medicine
state: Utah
city: Chesapeake
country: United States
facility: Chesapeake Pulmonary and Critical Care Medicine (PFT Only)
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater - Endoscopy Center
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Forest
country: United States
facility: Harman Eye Center (OCT only)
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates, Inc. (PFT only)
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula and Retina Center (OCT only)
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula and Retina Center (OCT only)
state: Virginia
city: Virginia Beach
country: United States
facility: Sleep Specialists of Tidewater - Virginia Beach (PFT Only)
state: Virginia
city: Birtinya
country: Australia
facility: Sunshine University Private Hospital
state: Queensland
city: Brisbane South
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Buderim
country: Australia
facility: Buderim Eye Centre (OCT Facility)
state: Queensland
city: Mackay
country: Australia
facility: Dr Shiran DeSilva Respiratory Clinic
state: Queensland
city: Mackay
country: Australia
facility: Mackay Discount Drug Store
state: Queensland
city: Mackay
country: Australia
facility: Mater Misericordiae Hospital
state: Queensland
city: Mackay
country: Australia
facility: Queensland X-Ray
state: Queensland
city: Mackay
country: Australia
facility: Vision Eye Institute Mackay
state: Queensland
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Elizabeth Specialist Suites (PFT Facility)
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital.
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Modbury
country: Australia
facility: Modbury Hospital (OCT Facility)
state: South Australia
city: Box Hill North
country: Australia
facility: Box Hill Eye Surgeons (OCT Facility)
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Camberwell
country: Australia
facility: Retina Specialists Victoria (OCT Facility)
state: Victoria
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Vision Eye Institute
state: Victoria
city: Bellfield
country: Australia
facility: MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility)
city: Birtinya
country: Australia
facility: Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
city: Brugge
country: Belgium
facility: AZ St Lucas Brugge
city: Roeselare
country: Belgium
facility: AZ Delta
city: Tournai
country: Belgium
facility: Centre Hospitalier Wallonie Picarde (CHWAPI)
city: Toronto
country: Canada
facility: Mount Sinai Services Inc. Dr George Charames
state: Ontario
city: Berlin
country: Germany
facility: Precision for Medicine GmbH
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Zurich
country: Switzerland
facility: Universtätsspital Zürich
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: