๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-20

Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma (NCT06572228)

AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Regeneron Pharmaceuticals

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: โ€ข What side effects may happen from taking dupilumab

Who can join: Review the eligibility criteria below.

Location: Kern Research, Inc โ€” Bakersfield, California

Age range: 12 Years to 80 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (77 Sites)

Showing the first 25 of 77 sites.

  • Kern Research, Inc โ€” Bakersfield, California
  • Modena Allergy & Asthma, Inc. โ€” La Jolla, California
  • Antelope Valley Clinical Trials โ€” Lancaster, California
  • Ark Clinical Research, LLC โ€” Long Beach, California
  • Newport Native Md, Inc. โ€” Newport Beach, California
  • Childrens Hospital of Orange County Main Campus โ€” Orange, California
  • Raffi Tachdjian MD, Inc. โ€” Santa Monica, California
  • Bensch Clinical Research โ€” Stockton, California
  • Integrated Research of Inland, Inc. โ€” Upland, California
  • Allianz Research Institute โ€” Westminster, California
  • National Jewish Health โ€” Denver, Colorado
  • St Francis Medical Institute โ€” Clearwater, Florida
  • Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration โ€” Kissimmee, Florida
  • Clinical Site Partners, LLC DBA Flourish Research โ€” Winter Park, Florida
  • Treasure Valley Medical Research โ€” Boise, Idaho
  • Sneeze Wheeze and Itch Associates โ€” Normal, Illinois
  • Asthma and Allergy Center of Chicago โ€” River Forest, Illinois
  • Endeavor Health, Skokie Campus โ€” Skokie, Illinois
  • University of Kansas Medical Center โ€” Kansas City, Kansas
  • Bluegrass Allergy Research โ€” Lexington, Kentucky
  • Family Allergy and Asthma Research Institute โ€” Louisville, Kentucky
  • Allergy & Asthma Specialists, P.S.C. โ€” Owensboro, Kentucky
  • Paul A. Shapero, M.D. โ€” Bangor, Maine
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Michigan Medicine โ€” Ann Arbor, Michigan

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Asthma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—