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

NCT06664619 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: FpA-AS-300932024-517991-39-00
• Study Type: interventional
• Target: 724
• Locations: 12 countries
• Sites: 156

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks

  Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.

  Baseline, Week 4

• Change from Baseline trough FEV1 at week 4

  Baseline, Week 4

Secondary Outcomes (10)

• Time to 15% improvement from baseline FEV1 post-dose on day 1

  Baseline to Post-dose on Day 1

• Time to 12% improvement from baseline FEV1 post-dose on day 1

  Baseline to Post-dose on Day 1

• Duration of 15% increase in FEV1 from baseline post-dose on day 1

  Baseline Pre-dose to Post-dose on Day 1

• Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5

  Baseline, Week 4

• Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3

  Baseline, Week 4

Study Arms (4)

Fp/ABS eMDPI

EXPERIMENTAL

Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module

Drug: Fp/ABS

Fp eMDPI

ACTIVE COMPARATOR

Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)

Drug: FP

ABS eMDPI

ACTIVE COMPARATOR

Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)

Drug: ABS

Placebo eMDPI

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Inhalation powder

Placebo eMDPI

FP DRUG

Inhalation powder

Also known as: fluticasone propionate

Fp eMDPI

ABS DRUG

Inhalation powder

Also known as: albuterol sulfate

ABS eMDPI

Fp/ABS DRUG

Inhalation powder

Also known as: fluticasone propionate/albuterol sulfate combination

Fp/ABS eMDPI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (156)

Teva Investigational Site 12087

Phoenix, Arizona, 85015, United States

RECRUITING

Teva Investigational Site 12144

Phoenix, Arizona, 85020, United States

COMPLETED

Teva Investigational Site 12104

Tucson, Arizona, 85715, United States

COMPLETED

Teva Investigational Site 12146

Tucson, Arizona, 85741, United States

RECRUITING

Teva Investigational Site 12102

Little Rock, Arkansas, 72205, United States

RECRUITING

Teva Investigational Site 12154

Encinitas, California, 92024-2812, United States

RECRUITING

Teva Investigational Site 12103

Huntington Beach, California, 92647, United States

RECRUITING

Teva Investigational Site 12068

La Palma, California, 90623, United States

RECRUITING

Teva Investigational Site 12152

Laguna Niguel, California, 92677, United States

RECRUITING

Teva Investigational Site 12145

Long Beach, California, 90815, United States

RECRUITING

Teva Investigational Site 12088

Los Angeles, California, 90048, United States

RECRUITING

Teva Investigational Site 12094

Los Angeles, California, 93551, United States

RECRUITING

Teva Investigational Site 12161

Northridge, California, 91324, United States

RECRUITING

Teva Investigational Site 12105

Oxnard, California, 93030-5822, United States

RECRUITING

Teva Investigational Site 12101

Sacramento, California, 95821, United States

RECRUITING

Teva Investigational Site 12064

San Jose, California, 95117, United States

RECRUITING

Teva Investigational Site 12109

Upland, California, 91786, United States

COMPLETED

Teva Investigational Site 12070

Vista, California, 92083, United States

COMPLETED

Teva Investigational Site 12091

Walnut Creek, California, 94598, United States

RECRUITING

Teva Investigational Site 12142

Lakewood, Colorado, 80228, United States

RECRUITING

Teva Investigational Site 12098

Lake City, Florida, 32055-4880, United States

COMPLETED

Teva Investigational Site 12118

Lake Worth, Florida, 33460-4400, United States

COMPLETED

Teva Investigational Site 12079

Melbourne, Florida, 32934, United States

RECRUITING

Teva Investigational Site 12071

Miami, Florida, 33126, United States

RECRUITING

Teva Investigational Site 12074

Miami, Florida, 33135, United States

RECRUITING

Teva Investigational Site 12086

Miami, Florida, 33173, United States

RECRUITING

Teva Investigational Site 12061

Miami, Florida, 33174, United States

COMPLETED

Teva Investigational Site 12097

Miami, Florida, 33175, United States

RECRUITING

Teva Investigational Site 12092

Miami Lakes, Florida, 33014, United States

COMPLETED

Teva Investigational Site 12076

North Miami Beach, Florida, 33169, United States

COMPLETED

Teva Investigational Site 12095

Palmetto Bay, Florida, 33157, United States

RECRUITING

Teva Investigational Site 12075

Pompano Beach, Florida, 33064, United States

RECRUITING

Teva Investigational Site 12078

Tampa, Florida, 33607, United States

RECRUITING

Teva Investigational Site 12175

Conyers, Georgia, 30012, United States

RECRUITING

Teva Investigational Site 12156

Boise, Idaho, 83706, United States

RECRUITING

Teva Investigational Site 12162

Westchester, Illinois, 60154, United States

RECRUITING

Teva Investigational Site 12081

Nottingham, Maryland, 21236, United States

COMPLETED

Teva Investigational Site 12106

Towson, Maryland, 21204, United States

RECRUITING

Teva Investigational Site 12157

White Marsh, Maryland, 21162-5503, United States

RECRUITING

Teva Investigational Site 12119

Boston, Massachusetts, 02115, United States

RECRUITING

Teva Investigational Site 12073

Minneapolis, Minnesota, 55402-2606, United States

COMPLETED

Teva Investigational Site 12066

Richfield, Minnesota, 55423, United States

RECRUITING

Teva Investigational Site 12149

Columbia, Missouri, 65203, United States

RECRUITING

Teva Investigational Site 12108

St Louis, Missouri, 63110, United States

RECRUITING

Teva Investigational Site 12089

St Louis, Missouri, 63141, United States

RECRUITING

Teva Investigational Site 12158

Hastings, Nebraska, 68901, United States

RECRUITING

Teva Investigational Site 12160

Las Vegas, Nevada, 89113, United States

RECRUITING

Teva Investigational Site 12150

Las Vegas, Nevada, 89119, United States

RECRUITING

Teva Investigational Site 12110

Jersey City, New Jersey, 07306, United States

RECRUITING

Teva Investigational Site 12167

Buffalo, New York, 14203, United States

RECRUITING

Teva Investigational Site 12115

Charlotte, North Carolina, 28207, United States

RECRUITING

Teva Investigational Site 12085

Raleigh, North Carolina, 27607-6689, United States

RECRUITING

Teva Investigational Site 12063

Toledo, Ohio, 43617, United States

RECRUITING

Teva Investigational Site 12155

Tulsa, Oklahoma, 74133, United States

RECRUITING

Teva Investigational Site 12170

Tulsa, Oklahoma, 74136, United States

RECRUITING

Teva Investigational Site 12117

Clackamas, Oregon, 97015, United States

COMPLETED

Teva Investigational Site 12151

Portland, Oregon, 97202, United States

RECRUITING

Teva Investigational Site 12147

Horsham, Pennsylvania, 19044, United States

COMPLETED

Teva Investigational Site 12072

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Teva Investigational Site 12114

Pittsburgh, Pennsylvania, 15241, United States

RECRUITING

Teva Investigational Site 12067

Columbia, South Carolina, 29204, United States

COMPLETED

Teva Investigational Site 12111

Myrtle Beach, South Carolina, 29572, United States

COMPLETED

Teva Investigational Site 12112

North Charleston, South Carolina, 29420, United States

COMPLETED

Teva Investigational Site 12107

Rock Hill, South Carolina, 29732, United States

RECRUITING

Teva Investigational Site 12083

Austin, Texas, 78744, United States

RECRUITING

Teva Investigational Site 12060

Austin, Texas, 78759, United States

RECRUITING

Teva Investigational Site 12077

Corsicana, Texas, 75110-2471, United States

COMPLETED

Teva Investigational Site 12159

Dallas, Texas, 75225-6301, United States

RECRUITING

Teva Investigational Site 12171

Dallas, Texas, 75235, United States

RECRUITING

Teva Investigational Site 12090

Dallas, Texas, 75243, United States

RECRUITING

Teva Investigational Site 12143

El Paso, Texas, 79912, United States

RECRUITING

Teva Investigational Site 12168

Houston, Texas, 77018, United States

RECRUITING

Teva Investigational Site 12080

Kingwood, Texas, 77339, United States

COMPLETED

Teva Investigational Site 12096

McKinney, Texas, 75069, United States

RECRUITING

Teva Investigational Site 12113

Mesquite, Texas, 75150, United States

RECRUITING

Teva Investigational Site 12084

Victoria, Texas, 77901, United States

RECRUITING

Teva Investigational Site 12148

Pleasant View, Utah, 84404-4791, United States

RECRUITING

Teva Investigational Site 12082

Salt Lake City, Utah, 84123, United States

COMPLETED

Teva Investigational Site 12153

South Ogden, Utah, 84405, United States

RECRUITING

Teva Investigational Site 12093

Portsmouth, Virginia, 23703, United States

COMPLETED

Teva Investigational Site 12062

Greenfield, Wisconsin, 53228, United States

RECRUITING

Teva Investigational Site 20154

Buenos Aires, C1426ABP, Argentina

RECRUITING

Teva Investigational Site 20156

Buenos Aires, S2013DTC, Argentina

RECRUITING

Teva Investigational Site 20157

Córdoba, X5003DCE, Argentina

RECRUITING

Teva Investigational Site 20150

Córdoba, X5014AKM, Argentina

RECRUITING

Teva Investigational Site 20145

Mar del Plata, 7600, Argentina

RECRUITING

Teva Investigational Site 20151

Mar del Plata, B7612ENA, Argentina

RECRUITING

Teva Investigational Site 20161

Mendoza, 5500, Argentina

RECRUITING

Teva Investigational Site 20146

Quilmes, 1878, Argentina

RECRUITING

Teva Investigational Site 20148

Rosario, 2013, Argentina

RECRUITING

Teva Investigational Site 20155

Rosario, S2000DEJ, Argentina

RECRUITING

Teva Investigational Site 20147

San Juan Bautista, B1853AIK, Argentina

RECRUITING

Teva Investigational Site 20152

San Miguel de Tucumán, 4000, Argentina

RECRUITING

Teva Investigational Site 20149

San Miguel de Tucumán, T4000IFL, Argentina

RECRUITING

Teva Investigational Site 59248

Haskovo, 6305, Bulgaria

RECRUITING

Teva Investigational Site 59251

Lovech, 5500, Bulgaria

RECRUITING

Teva Investigational Site 59249

Montana, 3400, Bulgaria

RECRUITING

Teva Investigational Site 59247

Pleven, 5800, Bulgaria

COMPLETED

Teva Investigational Site 59256

Sliven, 8800, Bulgaria

RECRUITING

Teva Investigational Site 59246

Sofia, 1142, Bulgaria

RECRUITING

Teva Investigational Site 59252

Sofia, 1233, Bulgaria

RECRUITING

Teva Investigational Site 59257

Sofia, 1421, Bulgaria

RECRUITING

Teva Investigational Site 59253

Sofia, 5400, Bulgaria

COMPLETED

Teva Investigational Site 59245

Stara Zagora, 6000, Bulgaria

RECRUITING

Teva Investigational Site 59254

Veliko Tarnovo, 5000, Bulgaria

RECRUITING

Teva Investigational Site 59250

Vratsa, 3000, Bulgaria

RECRUITING

Teva Investigational Site 54245

Jindřichův Hradec, 37738, Czechia

RECRUITING

Teva Investigational Site 54244

Teplice, 41501, Czechia

RECRUITING

Teva Investigational Site 54243

Varnsdorf, 40747, Czechia

RECRUITING

Teva Investigational Site 32881

Ahrensburg, 22926, Germany

RECRUITING

Teva Investigational Site 32880

Bendorf, 56170, Germany

RECRUITING

Teva Investigational Site 32884

Berlin, 10717, Germany

RECRUITING

Teva Investigational Site 32886

Berlin, 10787, Germany

RECRUITING

Teva Investigational Site 32879

Frankfurt, 60596, Germany

RECRUITING

Teva Investigational Site 32887

Leipzig, 04177, Germany

RECRUITING

Teva Investigational Site 32876

Leipzig, 04207, Germany

RECRUITING

Teva Investigational Site 32883

Leipzig - Nordost, 04347, Germany

COMPLETED

Teva Investigational Site 32877

Magdeburg, 39120, Germany

RECRUITING

Teva Investigational Site 32878

Mainz A. Rhein, 55128, Germany

RECRUITING

Teva Investigational Site 32888

Neu-Isenburg, 63263, Germany

RECRUITING

Teva Investigational Site 32890

Peine, 31224, Germany

RECRUITING

Teva Investigational Site 32882

Rheine, 48431, Germany

RECRUITING

Teva Investigational Site 80207

Be’er Ya‘aqov, 70300, Israel

COMPLETED

Teva Investigational Site 80206

Haifa, 3109601, Israel

RECRUITING

Teva Investigational Site 80208

Jerusalem, 91240, Israel

RECRUITING

Teva Investigational Site 21133

Chihuahua City, 31203, Mexico

RECRUITING

Teva Investigational Site 21134

Mexico City, 14090, Mexico

RECRUITING

Teva Investigational Site 21137

Morelia, 58260, Mexico

RECRUITING

Teva Investigational Site 21136

Tlalnepantla, 54055, Mexico

RECRUITING

Teva Investigational Site 21135

Zapopan, 45138, Mexico

RECRUITING

Teva Investigational Site 53582

Bialystok, 15-010, Poland

RECRUITING

Teva Investigational Site 53580

Bialystok, 15-430, Poland

RECRUITING

Teva Investigational Site 53578

Gdansk, 84-230, Poland

COMPLETED

Teva Investigational Site 53575

Lodz, 90-127, Poland

RECRUITING

Teva Investigational Site 53576

Lodz, 95-002, Poland

COMPLETED

Teva Investigational Site 53581

Maków Podhalański, 34-220, Poland

RECRUITING

Teva Investigational Site 53579

Poznan, 60-309, Poland

RECRUITING

Teva Investigational Site 53574

Tarnów, 70-332, Poland

RECRUITING

Teva Investigational Site 53577

Wroclaw, 50-381, Poland

RECRUITING

Teva Investigational Site 52148

Craiova, 410169, Romania

RECRUITING

Teva Investigational Site 52147

Oradea, 410169, Romania

RECRUITING

Teva Investigational Site 52145

Timișoara, 2447, Romania

RECRUITING

Teva Investigational Site 61090

Belgrade, 11000, Serbia

RECRUITING

Teva Investigational Site 61093

Belgrade, 11000, Serbia

RECRUITING

Teva Investigational Site 61092

Belgrade, 11070, Serbia

RECRUITING

Teva Investigational Site 61088

Belgrade, 11080, Serbia

RECRUITING

Teva Investigational Site 61094

Kragujevac, 34000, Serbia

RECRUITING

Teva Investigational Site 61095

Novi Sad, 21000, Serbia

RECRUITING

Teva Investigational Site 61091

Užice, 501715, Serbia

RECRUITING

Teva Investigational Site 62102

Košice, 04022, Slovakia

RECRUITING

Teva Investigational Site 62103

Martin, 03601, Slovakia

COMPLETED

Teva Investigational Site 62101

Spišská Nová Ves, 05201, Slovakia

RECRUITING

Teva Investigational Site 82089

Adana, 1330, Turkey (Türkiye)

RECRUITING

Teva Investigational Site 82085

Kirikkale, 71450, Turkey (Türkiye)

RECRUITING

Teva Investigational Site 82088

Kocaeli, 41140, Turkey (Türkiye)

RECRUITING

Teva Investigational Site 82087

Mersin, 33343, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Central Study Contacts

Teva U.S. Medical Information

CONTACT

1-888-483-8279; USMedInfo@tevapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (13); RO (3); US (81); CZ (3); BU (12); IL (3); ME (5); SL (3); TU (4); PL (9); DE (13); SE (7)