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New hope for asthma sufferers: dupilumab may beat higher steroid doses

NCT ID NCT06572228

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the injectable drug dupilumab (Dupixent) to a medium-dose inhaler works better than simply increasing the inhaler dose for people whose asthma is still not under control. About 120 adults with uncontrolled asthma will be randomly assigned to one of two groups. The goal is to see which approach reduces severe asthma attacks and improves breathing, while also tracking side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If successful, adding dupilumab to standard inhalers could offer a more effective way to control asthma and reduce severe attacks without needing higher steroid doses.
What could go wrong
This is a relatively small Phase 4 study, so results may not apply to all asthma patients. Dupilumab can cause injection-site reactions and other side effects, and the benefit over simply increasing inhaler dose may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document 2. Existing treatment with medium dose ICS/LABA (\>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1 3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study 4. Pre-bronchodilator FEV1, as defined in the protocol 5. Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol 6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period 7. ACQ-5 score ≥1.5 at screening (visit 1) 8. History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1 9. Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (\~90% of population), as defined in the protocol Key Exclusion Criteria: 1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments 2. Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging \[MRI\]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3) 3. A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol 4. Weight is less than 30 kilograms 5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years 6. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol 7. Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period NOTE: Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

    Wroclaw, PL-53-201, Poland

  • Allergy & Asthma Care of Waco

    Waco, Texas, 76712, United States

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301, United States

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Allergy Clinic NZOZ Homeo Medicus

    Bialystok, Podlaskie Voivodeship, 15-687, Poland

  • Allianz Research Institute

    Westminster, California, 92683, United States

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534, United States

  • Ark Clinical Research, LLC

    Long Beach, California, 90815, United States

  • Asthma and Allergy Center of Chicago

    River Forest, Illinois, 60305, United States

  • Baylor College of Medicine - Section of Pulmonary and Critical Care

    Houston, Texas, 77030, United States

  • Bensch Clinical Research

    Stockton, California, 95207, United States

  • Bluegrass Allergy Research

    Lexington, Kentucky, 40509, United States

  • Centrum Medycyny Oddechowej Mroz SJ

    Bialystok, Podlaskie Voivodeship, 15-044, Poland

  • Centrum Medyczne All-Med

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Certified Research Associates

    Cortland, New York, 13045, United States

  • Childrens Hospital of Orange County Main Campus

    Orange, California, 92868, United States

  • Cincinnati Childrens Hospital and Medical Center

    Cincinnati, Ohio, 45229, United States

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402, United States

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park, Florida, 32789, United States

  • Clinique de Specialisee en Allergie de la Capitale

    Québec, G1V 4W2, Canada

  • Dharma MD PA d/b/a Southwest Family Medicine Associates

    Dallas, Texas, 75235, United States

  • Diamond Clinic sp zoo

    Krakow, Malopolska, 31-559, Poland

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3, Canada

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5, Canada

  • Endeavor Health, Skokie Campus

    Skokie, Illinois, 60077, United States

  • European Trial Group (ETG) Warsaw

    Warsaw, Mazovian, 02-677, Poland

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario, M5G 1E2, Canada

  • Family Allergy and Asthma Research Institute

    Louisville, Kentucky, 40217, United States

  • Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

    Kissimmee, Florida, 34746, United States

  • Henderson Clinical Trials

    Henderson, Nevada, 89052, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • IKF Pneumologie Frankfurt GmbH & Co KG

    Frankfurt am Main, Hesse, 60596, Germany

  • IKF Pneumologie GmbH & Co. KG

    Mainz, 55128, Germany

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9, Canada

  • Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval

    Québec, G1V 4G5, Canada

  • Integrated Research of Inland, Inc.

    Upland, California, 91786, United States

  • Intermountain Medical Center - Murray (Pulmonary Medicine)

    Murray, Utah, 84107, United States

  • KPPK Studienzentrum

    Koblenz, Rhineland-Palatinate, 56068, Germany

  • Kern Research, Inc

    Bakersfield, California, 93301, United States

  • LMU University Hospital Munich

    Munich, Bavaria, 81377, Germany

  • Lekarze Specjaliści Małolepszy i Partnerzy

    Wroclaw, 54239, Poland

  • Lung Sleep Research Institute

    North Richland Hills, Texas, 76180, United States

  • Lungenpraxis Hohenzollerndamm RCMS

    Berlin, 10717, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Metroplex Pulmonary and Sleep Center, PA

    McKinney, Texas, 75069, United States

  • Michał Bogacki - DOBROSTAN

    Wroclaw, Lower Silesian Voivodeship, 53301, Poland

  • Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Modena Allergy & Asthma, Inc.

    La Jolla, California, 92037, United States

  • Montana Medical Research

    Missoula, Montana, 59808, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • New York Medical College

    Hawthorne, New York, 10532, United States

  • Newport Native Md, Inc.

    Newport Beach, California, 92663, United States

  • Northwell Health at ENT & Allergy Associates

    New York, New York, 10016, United States

  • POIS Sachsen GmbH iG

    Leipzig, 04347, Germany

  • PRCCI Clinical Research Center

    San Juan, 00927, Puerto Rico

  • Paul A. Shapero, M.D.

    Bangor, Maine, 04401, United States

  • Praxis fur Pneumologie am Duako

    Augsburg, Bavaria, 86150, Germany

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020, United States

  • Pulmonology Associates Inc.

    Wynnewood, Pennsylvania, 19096, United States

  • Raffi Tachdjian MD, Inc.

    Santa Monica, California, 90404, United States

  • Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology

    Rochester, New York, 14607, United States

  • Sneeze Wheeze and Itch Associates

    Normal, Illinois, 61761, United States

  • South Texas Allergy & Asthma Medical Professionals (STAAMP) Research

    San Antonio, Texas, 78229, United States

  • St Francis Medical Institute

    Clearwater, Florida, 33765, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Asthma and Allergy Center

    Bellevue, Nebraska, 68123, United States

  • The Lung Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Pittsburgh Asthma and Environmental Health Lung Institute

    Pittsburgh, Pennsylvania, 15213, United States

  • Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100, Denmark

  • Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)

    Lübeck, Schleswig-Holstein, 23552, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63119, United States

  • Western Sky Medical Research

    El Paso, Texas, 79912, United States

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