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AzTrials

AsthmaPhase 3NCT06664619

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

A Phase 3 study testing Fp/ABS, FP and ABS in people with Asthma, run by Teva Branded Pharmaceutical Products R&D LLC at 189 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Fp/ABS, FP and ABS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
649 participants
Where
189 sitesin 13 countries
Study dates
12 Dec 2024to 26 Oct 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

189 sites in 13 countries.

189 sites in 13 countries

United States91 sites

  • PPD Clinical Research

    Austin, Texas, 78744

  • Orion Clinical Research

    Austin, Texas, 78759

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bolt Clinical Research,LLC

    Brighton, Michigan, 48116

  • American Health Research, Inc.

    Charlotte, North Carolina, 28207

  • Portland Allergy and Asthma

    Clackamas, Oregon, 97015

  • Clinical Research of the Ozarks Inc

    Columbia, Missouri, 65203

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina, 29204

  • Oracle Clinical Research

    Conyers, Georgia, 30012

  • Corsicana Medical Research

    Corsicana, Texas, 75110-2471

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • Alina Clinical Trials, LLC, Barbara Baxter Sole MBR

    Dallas, Texas, 75225-6301

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Lonestar Clinical Research

    Dallas, Texas, 75243

  • Western Sky Medical Research

    El Paso, Texas, 79912

  • Office Of Dr. Warren W. Pleskow MD

    Encinitas, California, 92024-2812

  • Allergy, Asthma & Sinus Center, S.C.

    Greenfield, Wisconsin, 53228

  • Family Medical Center of Hastings

    Hastings, Nebraska, 68901

  • Peters Medical Research, LLC

    High Point, North Carolina, 27260

  • Hatboro Medical Associates - Avacare

    Horsham, Pennsylvania, 19044

  • Greater Heights Memorial Pulmonary and Sleep

    Houston, Texas, 77008-1528

  • SFF Research Group

    Houston, Texas, 77018

  • Innovative Medical Research of Texas LLC

    Houston, Texas, 77065

  • Allergy and Asthma Specialist Medical Group and Research Center

    Huntington Beach, California, 92647

  • Focus Clinical Research Solutions

    Jersey City, New Jersey, 07306

  • Sante Clinical Research LLC

    Kerrville, Texas, 78028

  • 3Sync Research - Houston

    Kingwood, Texas, 77339

  • IMAX Clinical Trials

    La Palma, California, 90623

  • Allergy and Asthma Associates of Southern California

    Laguna Niguel, California, 92677

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055-4880

  • 3Sync, LLC

    Lake Worth, Florida, 33460-4400

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228

  • Las Vegas Clinical Research Unit

    Las Vegas, Nevada, 89113

  • Santa Rosa Medical Centers of Nevada Avacare

    Las Vegas, Nevada, 89119

  • Acuro Research, Inc

    Little Rock, Arkansas, 72205

  • Ark Clinical Research

    Long Beach, California, 90815

  • Southern California Institute for Respiratory Diseases

    Los Angeles, California, 90048

  • California Allergy and Asthma Medical Group, Inc.

    Los Angeles, California, 93551

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

  • Optimal Research

    Melbourne, Florida, 32934

  • Epic Medical Research

    Mesquite, Texas, 75150

  • Angels Clinical Research Institute

    Miami, Florida, 33126

  • Suncoast Research Group LLC - Flourish

    Miami, Florida, 33135

  • Innova Pharma Research

    Miami, Florida, 33173

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Diverse Clinical Research, LLC

    Miami, Florida, 33175

  • San Marcus Research Clinic Inc

    Miami Lakes, Florida, 33014

  • Clinical Research Institute, Inc

    Minneapolis, Minnesota, 55402-2606

  • Trial Management Associates LLC - Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • National Allergy and Asthma Research LLC.

    North Charleston, South Carolina, 29420

  • Oceanic Research Group, LLC

    North Miami Beach, Florida, 33169

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Patient First Clinical Trials

    Nottingham, Maryland, 21236

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • FOMAT Medical Research

    Oxnard, California, 93030-5822

  • Innovation Medical Research Center - Alcanza

    Palmetto Bay, Florida, 33157

  • DM Clinical Research

    Philadelphia, Pennsylvania, 19107

  • Arizona Medical Clinic

    Phoenix, Arizona, 85015

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Allergy and Clinical Immunology Associates Pittsburgh

    Pittsburgh, Pennsylvania, 15241

  • Ogden Clinic - Mountain View

    Pleasant View, Utah, 84404-4791

  • D&H Pompano Research Center

    Pompano Beach, Florida, 33064

  • Northwest Research Center

    Portland, Oregon, 97202

  • Velocity Clinical Research - Family Practice - Suffolk

    Portsmouth, Virginia, 23703

  • North Carolina Clinical Research - CRN

    Raleigh, North Carolina, 27607-6689

  • Synexus Clinical Research US, Inc.

    Richfield, Minnesota, 55423

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Northern California Research

    Sacramento, California, 95821

  • Synexus Clinical Research US, Inc.

    Salt Lake City, Utah, 84123

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

  • Care Access - Shreveport

    Shreveport, Louisiana, 71105

  • Mayflower Clinical Research

    South Dartmouth, Massachusetts, 02747

  • South Ogden Family Medicine - Avacare

    South Ogden, Utah, 84405

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Siena Research Network

    Sugar Land, Texas, 77479

  • Clinical Research Trials of Florida, Inc

    Tampa, Florida, 33607

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • DM Clinical Tomball

    Tomball, Texas, 77081

  • Continental Clinical Research Solutions, LLC

    Towson, Maryland, 21204

  • Del Sol Research Management

    Tucson, Arizona, 85715

  • Novak Clinical Research

    Tucson, Arizona, 85741

  • Layrek Clinical Research

    Tulsa, Oklahoma, 74133

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

  • Integrated Research of lnland, Inc.

    Upland, California, 91786

  • Victoria Clinical Research Group

    Victoria, Texas, 77901

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • Allergy & Asthma Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Axis Clinical Research

    Westchester, Illinois, 60154

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland, 21162-5503

Other trials in United States

Argentina16 sites

  • Consultorios Medicos Dr. Doreski - PPDS

    Buenos Aires, C1426ABP

  • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

    Buenos Aires, S2013DTC

  • Instituto de Medicina Respiratoria, IMeR

    Córdoba, X5003DCE

  • Hospital de Ninos de La Santisima Trinidad

    Córdoba, X5014AKM

  • CEMER Centro Medico de Enfermedades Respiratorias

    Florida, B1602DQD

  • Instituto Ave Pulmo

    Mar del Plata, 7600

  • Centro de Investigaciones Medicas Mar del Plata (CIM-MDP)

    Mar del Plata, B7612ENA

  • Fundacion Scherbovsky

    Mendoza, 5500

  • Centro Respiratorio Quilmes

    Quilmes, 1878

  • Centro Respiratorio Infantil

    Rosario, 2013

  • Fundacion Estudios Clinicos

    Rosario, S2000DEJ

  • IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica

    San Juan Bautista, B1853AIK

  • Centro Integral de Medicina Respiratoria (CIMER)

    San Miguel de Tucumán, 4000

  • Instituto De Patologias Respiratorias

    San Miguel de Tucumán, 4000

  • Centro Modelo de Cardiologa SRL

    San Miguel de Tucumán, T4000IFL

  • Ibamedica

    Santa Fe, S3000ASF

Other trials in Argentina

Germany16 sites

  • Velocity Clinical Research - Ahrensburg

    Ahrensburg, 22926

  • KPPK Studienzentrum - Bendorf

    Bendorf, 56170

  • Lungenpraxis Hohenzollerndamm

    Berlin, 10717

  • Velocity Clinical Research - Berlin - PPDS

    Berlin, 10787

  • Klifeck GmbH

    Delitzsch, 04509

  • IKF Pneumologie

    Frankfurt, 60596

  • Medaimun GmbH

    Frankfurt, 60596

  • Velocity Clinical Research Leipzig GmbH

    Leipzig, 04177

  • Salvus-Klinische Studien GmbH

    Leipzig, 04207

  • POIS Sachsen GmbH

    Leipzig, 04347

  • SMO.MD GmbH - Zentrum fur klinische Studien

    Magdeburg, 39120

  • IKF Pneumologie Mainz

    Mainz, 55128

  • Ballenberger, Freytag Wenisch - Institut fur klinische Forschung GmbH

    Neu-Isenburg, 63263

  • Praxis Dr. med. Christian Schlenska

    Peine, 31224

  • framol-med GmbH

    Rheine, 48431

  • Lungenpraxis Witten

    Witten, 58452

Other trials in Germany

Bulgaria14 sites

  • MCpulmo-2018 Ltd

    Haskovo, 6305

  • Medical Centre Pratia Clinic EOOD

    Lovech, 5500

  • Medical Center Hera EOOD

    Montana, 3400

  • MHAT Stamen Iliev AD

    Montana, 3400

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases

    Rousse, 7002

  • Diagnostic - Consultative Center - Sliven OOD

    Sliven, 8800

  • First MHAT - Sofia

    Sofia, 1142

  • Multiprofile Hospital for Active Treatment Knyaginya Klementina

    Sofia, 1233

  • ?mbulatory-GPSMC in pediatric diseases Yuzhen Park

    Sofia, 1421

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

    Sofia, 5400

  • Medical Center New Rehabilitation Center Ltd

    Stara Zagora, 6000

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases

    Vratsa, 3000

Other trials in Bulgaria

Poland9 sites

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Bialystok, 15-010

  • Prywatna Praktyka Lekarska

    Bialystok, 15-430

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 84-230

  • Synexus Polska Sp. Z o.o. Oddzial w Lodzi

    Lodz, 90-127

  • Santa Familia PTG Lodz

    Lodz, 95-002

  • Makowskie Centrum Medyczne Hamernia Sp z oo

    Maków Podhalański, 34-220

  • EMC Instytut Medyczny SA PL CERTUS Szpital i Ambulatorium

    Poznan, 60-309

  • Alergo-Med Specjalistyczna Przychodnia Lekarska

    Tarnów, 70-332

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, 50-381

Other trials in Poland

Serbia9 sites

  • City Institute For Lung Diseases and TBC

    Belgrade, 11000

  • MSB Clinical Research Center

    Belgrade, 11000

  • University Clinical Center of Serbia - Koste Todorovica

    Belgrade, 11000

  • Mother and Child Health Institute of Serbia

    Belgrade, 11070

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • University Clinical Center Nis

    Niš, 18 000

  • Institute for Child and Youth Health Care of Vojvodina

    Novi Sad, 21000

  • Health Centre Uzice

    Užice, 501715

Other trials in Serbia

South Africa8 sites

  • Tiervlei Trial Centre

    Bellville, 7530

  • Worthwhile Clinical Trials

    Benoni, 1500

  • Langeberg Clinical Trials

    Cape Town, 7570

  • Meditrial - South Africa

    Pietermaritzburg, 944

  • Global Clinical Trials (Pty) Ltd

    Pretoria, 0157

  • MeCRU CRS

    Pretoria, 204

  • Khomanani Health Research and Wellness Centre

    Vhembe, 944

  • CareKahle Alexandra

    Wynberg, 2090

Other trials in South Africa

Czechia7 sites

  • MUDr. I. Cierna Peterova s.r.o.

    Brandýs nad Labem, 25001

  • HORNMED s.r.o.

    Brno, 618 00

  • MediTrial s.r.o.

    Jindřichův Hradec, 37738

  • Dawon s.r.o,pneumologicka ambulance

    Prague, 148 00

  • Prvni plicni ambulance s.r.o.

    Prague, 190 00

  • Plicni stredisko Teplice s.r.o.

    Teplice, 41501

  • PNEUMOLOGIE VARNSDORF s.r.o.

    Varnsdorf, 40747

Other trials in Czechia

Mexico5 sites

  • Mediadvance Clinical S.A.P.I. de C.V.

    Chihuahua City, 31203

  • Innovacion y Desarrollo en Ciencias de la Salud SRL de CV

    Mexico City, 14090

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, 58260

  • Clinical Research Institute- Mexico

    Tlalnepantla, 54055

  • CIMEZAP S de R.L. de C.V

    Zapopan, 45138

Other trials in Mexico

Romania4 sites

  • Angisan Grup srl

    Bucharest, 077025

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes

    Craiova, 410169

  • Spitalul de Pneumologie

    Oradea, 410169

  • Cabinet Pneumo Bronho Med

    Timișoara, 2447

Other trials in Romania

Turkey (Türkiye)4 sites

  • Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi

    Adana, 1330

  • Kirikkale Universitesi Tip Fakultesi Hastanesi

    Kirikkale, 71450

  • VM Medical Park Kocaeli Hastanesi

    Kocaeli, 41140

  • Mersin Universitesi Saglik Arastirma ve Uygulama Merkezi

    Mersin, 33343

Other trials in Turkey (Türkiye)

Israel3 sites

  • Shamir Medical Center (Asaf Harofeh)

    Be’er Ya‘aqov, 70300

  • Rambam Health Care Campus

    Haifa, 3109601

  • The Hadassah University Hospital-Ein Kerem

    Jerusalem, 91240

Other trials in Israel

Slovakia3 sites

  • Alersa s.r.o.

    Košice, 04022

  • Univerzitna nemocnica Martin

    Martin, 03601

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 05201

Other trials in Slovakia

About this study

Official title: 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.

Conditions
Asthma
Being tested
Fp/ABS, FP, ABS, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fp/ABSDrug

    Also called fluticasone propionate/albuterol sulfate combination

    Inhalation powder

  • FPDrug

    Also called fluticasone propionate

    Inhalation powder

  • ABSDrug

    Also called albuterol sulfate

    Inhalation powder

  • PlaceboDrug

    Inhalation powder

Study groups in NCT06664619
Study groupRoleWhat they receive
Fp/ABS eMDPIExperimentalFluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Receives: Drug: Fp/ABS
Fp eMDPIActive comparatorFluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
Receives: Drug: FP
ABS eMDPIActive comparatorAlbuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
Receives: Drug: ABS
Placebo eMDPIPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 4

  2. Change from Baseline trough FEV1 at week 4

    Measured: Baseline, Week 4

Secondary outcomes (10)

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

    Measured: Baseline to Post-dose on Day 1

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

    Measured: Baseline to Post-dose on Day 1

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

    Measured: Baseline Pre-dose to Post-dose on Day 1

  4. 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

    The ACQ-6 is a validated 6-item asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ has a possible score ranging from 0 (no impairment) to 6 (maximum impairment), and the total score is the mean of all responses. The total score ranging from 0 (totally controlled) to 6 (severely uncontrolled) with higher scores indicating maximum impairment.

    Measured: Baseline, Week 4

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

    The Asthma Control Test (ACT) is a participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items, with 4-week recall (on symptoms and daily functioning). It assesses the frequency of shortness of breath and general asthma symptoms, the use of rescue medications, the effect of asthma on daily functioning, and the overall self-assessment of asthma control measured on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

    Measured: Baseline, Week 4

  6. Number of participants with at least one treatment-emergent adverse event

    Measured: Up to Week 4

  7. Number of participants with at least one treatment-emergent serious adverse event

    Measured: Up to Week 4

  8. Number of participants who withdraw from treatment due to an adverse event

    Measured: Up to Week 4

  9. Plasma concentration of Fp

    Measured: Baseline, Week 4

  10. Plasma concentration of ABS

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start12 Dec 2024
  3. Primary completion26 Oct 2026
  4. Study completion26 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664619
Sponsor's protocol ID
FpA-AS-30093
Other IDs
2024-517991-39-00
Status last verified
Nov 2026
First submitted
28 Oct 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fp/ABS, FP and ABS in people with Asthma, run by Teva Branded Pharmaceutical Products R&D LLC at 189 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Argentina, Germany, Bulgaria, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks (time frame: Baseline, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06664619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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