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

Purpose

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.

Condition

  • Asthma

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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 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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fp/ABS eMDPI 		Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
  • Drug: Fp/ABS
    Inhalation powder
    Other names:
    • fluticasone propionate/albuterol sulfate combination
Active Comparator
Fp eMDPI 		Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
  • Drug: FP
    Inhalation powder
    Other names:
    • fluticasone propionate
Active Comparator
ABS eMDPI 		Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
  • Drug: Fp/ABS
    Inhalation powder
    Other names:
    • fluticasone propionate/albuterol sulfate combination
  • Drug: ABS
    Inhalation powder
    Other names:
    • albuterol sulfate
Placebo Comparator
Placebo eMDPI
  • Drug: Placebo
    Inhalation powder

Recruiting Locations

Teva Investigational Site 12087
Phoenix 5308655, Arizona 5551752 85015

Teva Investigational Site 12144
Phoenix 5308655, Arizona 5551752 85020

Teva Investigational Site 12146
Tucson 5318313, Arizona 5551752 85741

Teva Investigational Site 12102
Little Rock 4119403, Arkansas 4099753 72205

Teva Investigational Site 12154
Encinitas 5346646, California 5332921 92024-2812

Teva Investigational Site 12103
Huntington Beach 5358705, California 5332921 92647

Teva Investigational Site 12068
La Palma 5364022, California 5332921 90623

Teva Investigational Site 12145
Long Beach 5367929, California 5332921 90815

Teva Investigational Site 12088
Los Angeles 5368361, California 5332921 90048

Teva Investigational Site 12094
Los Angeles 5368361, California 5332921 93551

Teva Investigational Site 12161
Northridge 5377985, California 5332921 91324

Teva Investigational Site 12105
Oxnard 5380184, California 5332921 93030-5822

Teva Investigational Site 12101
Sacramento 5389489, California 5332921 95821

Teva Investigational Site 12064
San Jose 5392171, California 5332921 95117

Teva Investigational Site 12091
Walnut Creek 5406990, California 5332921 94598

Teva Investigational Site 12142
Lakewood 5427946, Colorado 5417618 80228

Teva Investigational Site 12079
Melbourne 4163971, Florida 4155751 32934

Teva Investigational Site 12071
Miami 4164138, Florida 4155751 33126

Teva Investigational Site 12074
Miami 4164138, Florida 4155751 33135

Teva Investigational Site 12086
Miami 4164138, Florida 4155751 33173

Teva Investigational Site 12097
Miami 4164138, Florida 4155751 33175

Teva Investigational Site 12095
Palmetto Bay 4167634, Florida 4155751 33157

Teva Investigational Site 12075
Pompano Beach 4169014, Florida 4155751 33064

Teva Investigational Site 12078
Tampa 4174757, Florida 4155751 33607

Teva Investigational Site 12156
Boise 5586437, Idaho 5596512 83706

Teva Investigational Site 12162
Westchester 4916140, Illinois 4896861 60154

Teva Investigational Site 12106
Towson 4371582, Maryland 4361885 21204

Teva Investigational Site 12157
White Marsh 4373426, Maryland 4361885 21162-5503

Teva Investigational Site 12119
Boston 4930956, Massachusetts 6254926 02115

Teva Investigational Site 12073
Minneapolis 5037649, Minnesota 5037779 55402-2606

Teva Investigational Site 12066
Richfield 5043193, Minnesota 5037779 55423

Teva Investigational Site 12149
Columbia 4381982, Missouri 4398678 65203

Teva Investigational Site 12108
St Louis 4407066, Missouri 4398678 63110

Teva Investigational Site 12089
St Louis 4407066, Missouri 4398678 63141

Teva Investigational Site 12158
Hastings 5069802, Nebraska 5073708 68901

Teva Investigational Site 12160
Las Vegas 5506956, Nevada 5509151 89113

Teva Investigational Site 12150
Las Vegas 5506956, Nevada 5509151 89119

Teva Investigational Site 12110
Jersey City 5099836, New Jersey 5101760 07306

Teva Investigational Site 12115
Charlotte 4460243, North Carolina 4482348 28207

Teva Investigational Site 12085
Raleigh 4487042, North Carolina 4482348 27607-6689

Teva Investigational Site 12063
Toledo 5174035, Ohio 5165418 43617

Teva Investigational Site 12155
Tulsa 4553433, Oklahoma 4544379 74133

Teva Investigational Site 12151
Portland 5746545, Oregon 5744337 97202

Teva Investigational Site 12072
Philadelphia 4560349, Pennsylvania 6254927 19107

Teva Investigational Site 12114
Pittsburgh 5206379, Pennsylvania 6254927 15241

Teva Investigational Site 12067
Columbia 4575352, South Carolina 4597040 29204

Teva Investigational Site 12107
Rock Hill 4593142, South Carolina 4597040 29732

Teva Investigational Site 12083
Austin 4671654, Texas 4736286 78744

Teva Investigational Site 12060
Austin 4671654, Texas 4736286 78759

Teva Investigational Site 12159
Dallas 4684888, Texas 4736286 75225-6301

Teva Investigational Site 12090
Dallas 4684888, Texas 4736286 75243

Teva Investigational Site 12143
El Paso 5520993, Texas 4736286 79912

Teva Investigational Site 12096
McKinney 4710178, Texas 4736286 75069

Teva Investigational Site 12084
Victoria 4739157, Texas 4736286 77901

Teva Investigational Site 12148
Pleasant View 5779833, Utah 5549030 84404-4791

Teva Investigational Site 12153
South Ogden 5781783, Utah 5549030 84405

Teva Investigational Site 12062
Greenfield 5255068, Wisconsin 5279468 53228

More Details

NCT ID
NCT06664619
Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center