Befejeződött3. fázis

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

Key facts

Where: Austin, Boise, Boston, Brighton, Charlotte, Clackamas, Columbia, Conyers, Corsicana, Cypress, Dallas, El Paso, Encinitas, Greenfield, Hastings, High Point, Horsham, Houston, Huntington Beach, Jersey City, Kerrville, Kingwood, La Palma, Laguna Niguel, Lake City, Lake Worth, Lakewood, Las Vegas, Little Rock, Long Beach, Los Angeles, McKinney, Melbourne, Mesquite, Miami, Miami Lakes, Minneapolis, Myrtle Beach, North Charleston, North Miami Beach, Northridge, Nottingham, Oklahoma City, Oxnard, Palmetto Bay, Philadelphia, Phoenix, Pittsburgh, Pleasant View, Pompano Beach, Portland, Portsmouth, Raleigh, Richfield, Rock Hill, Sacramento, Salt Lake City, San Jose, Shreveport, South Dartmouth, South Ogden, St Louis, Sugar Land, Tampa, Toledo, Tomball, Towson, Tucson, Tulsa, Upland, Victoria, Vista, Walnut Creek, Westchester és White Marsh, Egyesült ÁllamokSee the 91 sites
Phase: 3. fázis

Where in Egyesült Államok

Orion Clinical ResearchAustin, Egyesült ÁllamokNo longer taking part
PPD Clinical ResearchAustin, Egyesült ÁllamokNo longer taking part
Treasure Valley Medical ResearchBoise, Egyesült ÁllamokNo longer taking part
Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
Bolt Clinical Research,LLCBrighton, Egyesült ÁllamokNo longer taking part
American Health Research Inc.Charlotte, Egyesült ÁllamokNo longer taking part
Portland Allergy and AsthmaClackamas, Egyesült ÁllamokNo longer taking part
Clinical Research of the Ozarks IncColumbia, Egyesült ÁllamokNo longer taking part
Velocity Clinical Research, ColumbiaColumbia, Egyesült ÁllamokNo longer taking part
Oracle Clinical ResearchConyers, Egyesült ÁllamokNo longer taking part
Corsicana Medical ResearchCorsicana, Egyesült ÁllamokNo longer taking part
Horizon Clinical Research GroupCypress, Egyesült ÁllamokNo longer taking part
Alina Clinical Trials, LLC, Barbara Baxter Sole MBRDallas, Egyesült ÁllamokNo longer taking part
Lonestar Clinical ResearchDallas, Egyesült ÁllamokNo longer taking part
Southwest Family Medicine AssociatesDallas, Egyesült ÁllamokNo longer taking part
Western Sky Medical ResearchEl Paso, Egyesült ÁllamokNo longer taking part
Office Of Dr. Warren W. Pleskow MDEncinitas, Egyesült ÁllamokNo longer taking part
Allergy, Asthma & Sinus Center, S.C.Greenfield, Egyesült ÁllamokNo longer taking part
Family Medical Center of HastingsHastings, Egyesült ÁllamokNo longer taking part
Peters Medical Research, LLCHigh Point, Egyesült ÁllamokNo longer taking part
Hatboro Medical Associates - AvacareHorsham, Egyesült ÁllamokNo longer taking part
Greater Heights Memorial Pulmonary and SleepHouston, Egyesült ÁllamokNo longer taking part
Innovative Medical Research of Texas LLCHouston, Egyesült ÁllamokNo longer taking part
SFF Research GroupHouston, Egyesült ÁllamokNo longer taking part
Allergy and Asthma Specialist Medical Group and Research CenterHuntington Beach, Egyesült ÁllamokNo longer taking part
Focus Clinical Research SolutionsJersey City, Egyesült ÁllamokNo longer taking part
Sante Clinical Research LLCKerrville, Egyesült ÁllamokNo longer taking part
3Sync Research - HoustonKingwood, Egyesült ÁllamokNo longer taking part
IMAX Clinical TrialsLa Palma, Egyesült ÁllamokNo longer taking part
Allergy and Asthma Associates of Southern CaliforniaLaguna Niguel, Egyesült ÁllamokNo longer taking part
Multi-Specialty Research Associates, Inc.Lake City, Egyesült ÁllamokNo longer taking part
3Sync, LLCLake Worth, Egyesült ÁllamokNo longer taking part
Critical Care, Pulmonary and Sleep AssociatesLakewood, Egyesült ÁllamokNo longer taking part
Las Vegas Clinical Research UnitLas Vegas, Egyesült ÁllamokNo longer taking part
Santa Rosa Medical Centers of Nevada AvacareLas Vegas, Egyesült ÁllamokNo longer taking part
Acuro Research, IncLittle Rock, Egyesült ÁllamokNo longer taking part
Ark Clinical ResearchLong Beach, Egyesült ÁllamokNo longer taking part
California Allergy and Asthma Medical Group, Inc.Los Angeles, Egyesült ÁllamokNo longer taking part
Southern California Institute for Respiratory DiseasesLos Angeles, Egyesült ÁllamokNo longer taking part
Metroplex Pulmonary and Sleep CenterMcKinney, Egyesült ÁllamokNo longer taking part
Optimal ResearchMelbourne, Egyesült ÁllamokNo longer taking part
Epic Medical ResearchMesquite, Egyesült ÁllamokNo longer taking part
Angels Clinical Research InstituteMiami, Egyesült ÁllamokNo longer taking part
Diverse Clinical Research LLCMiami, Egyesült ÁllamokNo longer taking part
Florida Research Center, Inc.Miami, Egyesült ÁllamokNo longer taking part
Innova Pharma ResearchMiami, Egyesült ÁllamokNo longer taking part
Suncoast Research Group LLC - FlourishMiami, Egyesült ÁllamokNo longer taking part
San Marcus Research Clinic, Inc.Miami Lakes, Egyesült ÁllamokNo longer taking part
Clinical Research Institute, Inc.Minneapolis, Egyesült ÁllamokNo longer taking part
Trial Management Associates LLC - Myrtle BeachMyrtle Beach, Egyesült ÁllamokNo longer taking part
National Allergy and Asthma Research, LLCNorth Charleston, Egyesült ÁllamokNo longer taking part
Oceanic Research Group, LLCNorth Miami Beach, Egyesült ÁllamokNo longer taking part
California Medical Research Associates Inc.Northridge, Egyesült ÁllamokNo longer taking part
Patient First Clinical TrialsNottingham, Egyesült ÁllamokNo longer taking part
Allergy Asthma and Clinical Research CenterOklahoma City, Egyesült ÁllamokNo longer taking part
Fomat Medical ResearchOxnard, Egyesült ÁllamokNo longer taking part
Innovation Medical Research Center - AlcanzaPalmetto Bay, Egyesült ÁllamokNo longer taking part
DM Clinical ResearchPhiladelphia, Egyesült ÁllamokNo longer taking part
Arizona Medical ClinicPhoenix, Egyesült ÁllamokNo longer taking part
Central Phoenix Medical ClinicPhoenix, Egyesült ÁllamokNo longer taking part
Allergy and Clinical Immunology Associates PittsburghPittsburgh, Egyesült ÁllamokNo longer taking part
Ogden Clinic - Mountain ViewPleasant View, Egyesült ÁllamokNo longer taking part
D & H Pompano Research CenterPompano Beach, Egyesült ÁllamokNo longer taking part
Northwest Research CenterPortland, Egyesült ÁllamokNo longer taking part
Velocity Clinical Research - Family Practice - SuffolkPortsmouth, Egyesült ÁllamokNo longer taking part
North Carolina Clinical Research - CRNRaleigh, Egyesült ÁllamokNo longer taking part
Synexus Clinical Research US IncRichfield, Egyesült ÁllamokNo longer taking part
Clinical Research of Rock HillRock Hill, Egyesült ÁllamokNo longer taking part
Northern California ResearchSacramento, Egyesült ÁllamokNo longer taking part
Synexus Clinical Research US, Inc.Salt Lake City, Egyesült ÁllamokNo longer taking part
Allergy and Asthma Associates of Santa Clara Valley Research CenterSan Jose, Egyesült ÁllamokNo longer taking part
Care Access - ShreveportShreveport, Egyesült ÁllamokNo longer taking part
Mayflower Clinical ResearchSouth Dartmouth, Egyesült ÁllamokNo longer taking part
South Ogden Family Medicine - AvacareSouth Ogden, Egyesült ÁllamokNo longer taking part
The Clinical Research Center, LLCSt Louis, Egyesült ÁllamokNo longer taking part
Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
Siena Research NetworkSugar Land, Egyesült ÁllamokNo longer taking part
Clinical Research Trials of Florida, Inc.Tampa, Egyesült ÁllamokNo longer taking part
Toledo Institute of Clinical ResearchToledo, Egyesült ÁllamokNo longer taking part
DM Clinical TomballTomball, Egyesült ÁllamokNo longer taking part
Continental Clinical Research Solutions, LLCTowson, Egyesült ÁllamokNo longer taking part
Del Sol Research ManagementTucson, Egyesült ÁllamokNo longer taking part
Novak Clinical ResearchTucson, Egyesült ÁllamokNo longer taking part
Layrek Clinical ResearchTulsa, Egyesült ÁllamokNo longer taking part
Vital Prospects Clinical Research Institute., PCTulsa, Egyesült ÁllamokNo longer taking part
Integrated Research of lnland, Inc.Upland, Egyesült ÁllamokNo longer taking part
Victoria Clinical Research GroupVictoria, Egyesült ÁllamokNo longer taking part
Synexus Clinical Research US, Inc.Vista, Egyesült ÁllamokNo longer taking part
Allergy & Asthma Clinical Research, Inc.Walnut Creek, Egyesült ÁllamokNo longer taking part
Axis Clinical ResearchWestchester, Egyesült ÁllamokNo longer taking part
Chesapeake Clinical Research, Inc.White Marsh, Egyesült ÁllamokNo longer taking part

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: Teva Branded Pharmaceutical Products R&D LLC
Trial code: NCT06664619 EU 2024-517991-39-00
Record updated: 2026. november 4.
Original description: The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).Read full original descriptionShow less
A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma
The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).
Secondary objectives are:
* To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose
The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.
Inclusion: The participant has a diagnosis of asthma of at least 6 months duration; Participants currently receive a beta-agonist (eg, salbutamol [albuterol] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication; If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the trial), or is of non-childbearing potential; NOTE- Additional criteria apply, please contact the investigator for more information.
Exclusion: The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering screening; The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode; The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded; The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome; NOTE- Additional criteria apply, please contact the investigator for more information.
ClinicalTrials.gov NCT06664619 · EU CTIS 2024-517991-39-00