Study of dupilumab added to inhaled corticosteroids and long-acting beta-agonists compared to high-dose inhaled therapy in adolescents and adults with uncontrolled asthma

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What is this study about?

This study focuses on uncontrolled asthma in adolescents and adults who are currently using medium-dose inhaled medications. The research compares two different treatment approaches: adding dupilumab to the current treatment versus increasing the dose of existing medication. The current treatment includes Advair HFA, which contains two active substances: fluticasone propionate and salmeterol.

The main purpose is to determine if adding dupilumab to the current medium-dose treatment is more effective at reducing severe asthma attacks compared to increasing the dose of Advair HFA. Some participants will receive dupilumab injections under the skin, while others will receive placebo injections. All participants will continue using their asthma inhalers throughout the study.

The study treatment will continue for approximately one year. During this time, participants will need to use their prescribed medications regularly and attend clinic visits for monitoring their asthma condition. The study will track various aspects of breathing function and how well asthma symptoms are controlled. The medications used in this study are designed to help control inflammation in the airways and make breathing easier for people with asthma.

1 Initial medication period

You will continue using your current medium dose ICS/LABA inhaler (containing fluticasone propionate and salmeterol) for at least 3 months with a stable dose

Your current inhaler must be used consistently, at least 80% of prescribed days

2 Treatment assignment

You will be assigned to one of two treatment groups:

Group 1: Dupixent (dupilumab) 300 mg injection under the skin plus medium dose inhaler

Group 2: High-dose inhaler (Advair HFA 230mcg/21mcg) plus placebo injection

3 Regular assessments

Your lung function will be measured through breathing tests that check:

– How much air you can breathe out in one second (FEV1)

– How much air you can exhale in total (FVC)

– How fast you can blow air out (peak flow)

You will complete questionnaires about your asthma control (ACQ-5)

4 Monitoring period

The study will continue until December 2026

Any breathing problems or asthma attacks will be recorded

Any side effects from the medications will be documented

Your use of additional asthma medications will be tracked

Who Can Join the Study?

Must be between 12 and 80 years old when signing the consent form and have been diagnosed with asthma for at least 12 months
Must be currently using medium-dose inhaled corticosteroids (ICS) with long-acting beta-agonists (LABA) for at least 3 months, with a stable dose for at least 1 month before the first visit
Can be using up to 3 different asthma control medications
Must show improvement in lung function tests (FEV1 – the amount of air you can forcefully exhale in one second) after using an inhaler with albuterol/salbutamol
Must demonstrate regular use of prescribed asthma medications on at least 80% of days during the initial study period
Must have an ACQ-5 score of 1.5 or higher at the first screening visit (ACQ-5 is a questionnaire that measures how well your asthma is controlled)
Must have experienced at least 1 severe asthma flare-up in the past year, but not in the 30 days before the first visit
Must have a blood test showing 300 or more eosinophil cells (a type of white blood cell) per microliter of blood at the first visit

Who Cannot Join the Study?

Patients who have participated in any clinical trial within the past 30 days
Individuals with severe lung diseases other than asthma
Current smokers or those who quit smoking less than 6 months ago
People with a history of chronic obstructive pulmonary disease (COPD) – a long-term lung condition that causes breathing difficulties
Those with known allergies or sensitivity to dupilumab or similar medications
Patients with active parasitic infections
People with significant heart, liver, or kidney problems
Those with uncontrolled high blood pressure
Pregnant or breastfeeding women
Patients using medications that could interfere with the study drug
People with a history of cancer in the past 5 years (except for successfully treated skin cancer)
Individuals with serious infections requiring hospitalization in the past 4 weeks
Those with poorly controlled diabetes
Patients who have received any biological therapy for asthma in the past 4 months
People with a history of alcohol or drug abuse in the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Diamond Clinic Sp. z o.o.	Cracow	Poland
Research Center for Medical Studies (RCMS)	Berlin	Germany

Other Sites

Site Name	City	Country
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Lekarze Specjalisci J. Malolepszy I Partnerzy	Wroclaw	Poland
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
POIS Sachsen GmbH	Leipzig	Germany
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft	Augsburg	Germany
Hnfvlnko Hujgcfec	Hvidovre	Denmark
&uapbvnzujmltaojwhgit Swkhwcnkxkzxita Odfpii Mzkevavq Mohwahvr Itkhsqmh Bibnfory Mglyl Jsxif	Wroclaw	Poland
Nkix Hehby Mhbghrq	Bialystok	Poland
Mbwsgl Bnqjprv – Drdprsiad	Wroclaw	Poland
Hmvbjh Hxnwhmil	Herlev	Denmark
Kdatwkaq dpi Umwvxfzqxsrr Mgxfcvhb Aha	Munich	Germany
Udjrnceulveifu Cwptfuf Kirdmucpg	Gdansk	Poland
Kqds Gbtz	Bendorf	Germany

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.10.2024
Germany	Not recruiting	15.10.2024
Poland	Not recruiting	15.10.2024

Trial locations

Investigated drugs:

Dupilumab is a medication used to treat severe asthma. It works by blocking certain proteins in the body that cause inflammation in the airways. This medication is given as an injection and helps reduce asthma attacks in people whose asthma is not well controlled with other medications.

Inhaled Corticosteroids (ICS) are anti-inflammatory medications that help reduce swelling and mucus production in the airways. They are taken through an inhaler and help prevent asthma symptoms.

Long-Acting Beta Agonists (LABA) are medications that help relax and open the airways. They are typically used together with inhaled corticosteroids in a combination inhaler. These medications provide long-lasting relief of asthma symptoms by keeping the airways open for an extended period.

Investigated diseases:

Asthma

Asthma – A chronic respiratory condition that affects the airways in the lungs, causing them to become inflamed and narrowed. The airways become sensitive to various triggers such as allergens, irritants, or physical activity, leading to recurring episodes of breathing difficulties. During an asthma episode, the muscles around the airways tighten, the lining of the airways becomes swollen, and more mucus is produced than usual. These changes cause symptoms like wheezing, coughing, chest tightness, and shortness of breath. The severity of symptoms can vary from mild to severe, and they may come and go over time.

Trial ID:

2023-510458-18-00

Protocol code:

R668-AS-2373

NCT ID:

NCT06572228

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of dupilumab added to inhaled corticosteroids and long-acting beta-agonists compared to high-dose inhaled therapy in adolescents and adults with uncontrolled asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?