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
Public ClinicalTrials.gov record NCT06572228. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: • What side effects may happen from taking dupilumab
Study identification
- NCT ID
- NCT06572228
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2024 (Actual)
- Primary completion
- Apr 24, 2027 (Estimated)
- Completion
- Apr 24, 2027 (Estimated)
- Last update posted
- May 22, 2026
2024 – 2027
United States locations
- U.S. sites
- 51
- U.S. states
- 22
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kern Research, Inc | Bakersfield | California | 93301 | — |
| Modena Allergy & Asthma, Inc. | La Jolla | California | 92037 | — |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | — |
| Ark Clinical Research, LLC | Long Beach | California | 90815 | — |
| Newport Native Md, Inc. | Newport Beach | California | 92663 | — |
| Childrens Hospital of Orange County Main Campus | Orange | California | 92868 | — |
| Raffi Tachdjian MD, Inc. | Santa Monica | California | 90404 | — |
| Bensch Clinical Research | Stockton | California | 95207 | — |
| Integrated Research of Inland, Inc. | Upland | California | 91786 | — |
| Allianz Research Institute | Westminster | California | 92683 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| St Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration | Kissimmee | Florida | 34746 | — |
| Clinical Site Partners, LLC DBA Flourish Research | Winter Park | Florida | 32789 | — |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | — |
| Sneeze Wheeze and Itch Associates | Normal | Illinois | 61761 | — |
| Asthma and Allergy Center of Chicago | River Forest | Illinois | 60305 | — |
| Endeavor Health, Skokie Campus | Skokie | Illinois | 60077 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Bluegrass Allergy Research | Lexington | Kentucky | 40509 | — |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40217 | — |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | — |
| Paul A. Shapero, M.D. | Bangor | Maine | 04401 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | — |
| Washington University School of Medicine | St Louis | Missouri | 63119 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| The Asthma and Allergy Center | Bellevue | Nebraska | 68123 | — |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | — |
| Certified Research Associates | Cortland | New York | 13045 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| Northwell Health at ENT & Allergy Associates | New York | New York | 10016 | — |
| Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology | Rochester | New York | 14607 | — |
| Cincinnati Childrens Hospital and Medical Center | Cincinnati | Ohio | 45229 | — |
| Allergy Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | — |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | 15801 | — |
| University of Pittsburgh Asthma and Environmental Health Lung Institute | Pittsburgh | Pennsylvania | 15213 | — |
| Pulmonology Associates Inc. | Wynnewood | Pennsylvania | 19096 | — |
| Dharma MD PA d/b/a Southwest Family Medicine Associates | Dallas | Texas | 75235 | — |
| Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas | 75020 | — |
| Western Sky Medical Research | El Paso | Texas | 79912 | — |
| Baylor College of Medicine - Section of Pulmonary and Critical Care | Houston | Texas | 77030 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Metroplex Pulmonary and Sleep Center, PA | McKinney | Texas | 75069 | — |
| Lung Sleep Research Institute | North Richland Hills | Texas | 76180 | — |
| South Texas Allergy & Asthma Medical Professionals (STAAMP) Research | San Antonio | Texas | 78229 | — |
| Allergy & Asthma Care of Waco | Waco | Texas | 76712 | — |
| Intermountain Medical Center - Murray (Pulmonary Medicine) | Murray | Utah | 84107 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06572228, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06572228 live on ClinicalTrials.gov.