Study on the Long-term Effects of Dupilumab in Preventing Lung Function Decline in Adults with Uncontrolled Moderate to Severe Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dupilumab on patients with uncontrolled moderate to severe Asthma. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study aims to see if Dupilumab can help prevent or slow down the decline in lung function over time. Dupilumab is given as a solution for injection using a pre-filled syringe. Some participants in the study will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to assess the long-term effects of Dupilumab on lung function in adults with moderate to severe asthma. Participants will be randomly assigned to receive either Dupilumab or a placebo. The study will last for a period of up to three years, during which participants will receive regular injections and attend scheduled visits to monitor their lung function and overall health. The study will help determine if Dupilumab can effectively prevent or reduce the rate of lung function decline in people with asthma.

Throughout the study, participants will undergo various assessments to track changes in their lung function and asthma symptoms. These assessments will include measuring the amount of air they can exhale forcefully, known as Forced Expiratory Volume (FEV1), and monitoring levels of a marker called FeNO, which indicates inflammation in the airways. The study will also evaluate the frequency of severe asthma attacks and any changes in asthma control and quality of life. The results will provide valuable information on the potential benefits of Dupilumab for individuals with moderate to severe asthma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of asthma and ensuring that current treatments are stable.

Eligibility criteria include being at least 18 years old, having a history of asthma for at least 12 months, and meeting specific lung function requirements.

2 randomization

Participants are randomly assigned to receive either dupilumab or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

Dupilumab is administered as a subcutaneous injection using a pre-filled syringe.

3 treatment phase

The treatment phase lasts for 52 weeks. During this time, participants receive regular injections of either dupilumab or placebo.

The primary goal is to assess the effect of the treatment on lung function over this period.

4 follow-up assessments

Throughout the study, regular follow-up assessments are conducted to monitor lung function and overall health.

These assessments include measuring lung capacity and evaluating asthma control.

5 final evaluation

At the end of the 52-week treatment period, a final evaluation is conducted to assess the long-term effects of the treatment on lung function.

The study aims to determine if dupilumab can prevent or slow the decline in lung function compared to placebo.

Who Can Join the Study?

Participant must be at least 18 years old, or the legal age of consent in their area, at the time of signing the consent form.
Must have been diagnosed with asthma by a doctor for at least 12 months.
Must be using medium to high dose inhaled corticosteroids (medications to reduce inflammation in the lungs) along with another asthma controller medication, with a stable dose for at least 1 month before the first visit. If a third or fourth controller medication is needed, it should also be on a stable dose for at least 1 month before the first visit.
Pre-bronchodilator forced expiratory volume (FEV1), which measures lung function, should be 80% or less of the predicted normal value for adults at the first and second visits, before randomization.
Asthma Control Questionnaire (ACQ-5) score should be 1.5 or higher at the first and second visits, before randomization. This questionnaire helps assess how well asthma is being controlled.
Must show variable airflow obstruction, which means changes in how air moves in and out of the lungs. This can be shown by one or more of the following:
- Positive reversibility test: Improvement of at least 12% and 200 mL in FEV1 after using a short-acting bronchodilator, either before randomization or documented in the past 24 months.
- Positive bronchial challenge test: A drop in FEV1 of 20% or more with a standard dose of methacholine, or 15% or more with hyperventilation, hypertonic saline, or mannitol challenge, either before randomization or documented in the past 24 months.
- Average daily peak flow variability of more than 10% over a 2-week period, documented in the past 24 months before the first screening visit.
- Airflow variability in clinic FEV1 of more than 12% and 200 mL between visits, outside of respiratory infections, documented in the past 24 months before the first screening visit.
- FEV1 increases by more than 12% and 200 mL from baseline after 4 weeks of anti-inflammatory treatment.
A reversibility test may be attempted up to three times during the screening period until the baseline visit to meet the criteria for reversibility, if not already documented in the past 24 months before the first visit.
FeNO (a marker of inflammation in the airways) should be 35 parts per billion or higher at the second visit, before randomization.
Must have a history of at least one severe asthma exacerbation in the previous year before the first visit, defined as a worsening of asthma that required:
- Use of systemic corticosteroids for 3 or more days; or
- Hospitalization or emergency room visit due to asthma, requiring systemic corticosteroids.

Who Cannot Join the Study?

Patients with other serious lung diseases besides asthma cannot participate. This means if you have a different lung condition, you may not be eligible.
Individuals who have had a recent severe asthma attack that required hospitalization may be excluded. This refers to a serious asthma episode that needed you to stay in the hospital.
People who are currently using certain medications that might interfere with the study treatment may not be allowed to join. This means if you are taking specific drugs that could affect the study results, you might not be eligible.
Participants with a history of severe allergic reactions to similar treatments may be excluded. This means if you have had a strong allergic response to treatments like the one being studied, you might not be able to participate.
Individuals with certain medical conditions that could affect the study outcomes may not be eligible. This means if you have other health issues that could influence the study, you might not be able to join.
Pregnant or breastfeeding women are usually not allowed to participate. This means if you are expecting a baby or nursing, you might not be eligible for the study.
People who have participated in another clinical trial recently may be excluded. This means if you have been part of another study not long ago, you might not be able to join this one.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD	Sofia	Bulgaria
Medical Center Teodora EOOD	Ruse	Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD	Vratsa	Bulgaria
424 Military General Training Hospital	Thessaloniki	Greece
Crednoron Umejherzewtjly Stkvzmewm	Woluwe-Saint-Lambert	Belgium
Uivswwxpqp Oo Dydkoypi	Debrecen	Hungary
Ozdydurav Eiprny Kxyo	Mosonmagyaróvár	Hungary
Ldvnl Gkaxlou Hcjfseon Oi Aqzepo	Athens	Greece
Mqemved Clfzqi Pqgrfkkvduw Lcys	Sofia	Bulgaria
Uytefbgdbp Gzfitzx Halvuzzc Oq Izqsvhpe	Ioannina	Greece
Ejvitzjerodkpiefndzfmkrruw Hmxebxht ow Akodjb	Athens	Greece
Ddlurfsmkyhoawqyzabouxl colaqt “znzalmcyhgfbmrv Edby	Sofia	Bulgaria
Adylfj Mzibdiw Cmxrhn Shuh	Thessaloniki	Greece
Unebyvlmoz Guecwth Hihztham Ou Agvgresgbzogbk	Alexandroupoli	Greece
Sw Vissvugsfuraoft Ufpjykbsaj Hornumpm	Dublin	Ireland
Cmcmyf hnxkaarwwhy uyxoelyhrfisj dm Lgahu	Liege	Belgium
Cvfqpyg Mnhlxuu Dg Dqwbvqpclt Sz Tbpfchjqi Avxeyxgfe Nkojau Swtqnw	Brasov	Romania
Gxstdo Njanfmgfxd Tiatyyvxecmob Gfnblx Prhcukuixifn	Thessaloniki	Greece
Atlejw Nvafh Hrtqziam	Athens	Greece
Uycktuofct Gxsumng Hvlhcbpo Asnwqva Gvhtror Hbxkktnt Oo Wqdv Accsfb H Akez Vabcaix	Chaidari	Greece
4oe Gpdjeww Mxspcosh Hwxsuiti Oe Aznjkn	Athens	Greece
Uoabygyoja Tlicwxph Huvrretc Momxqesahbzs	Szombathely	Hungary
Mqaxghx Chmdxg Eqtrtkdjk Ovc	Sofia	Bulgaria
Ubyxcy Mccffcj Cmtcgu Eojd	Plovdiv	Bulgaria
Acbbgxs Gkoe Sbypry	Bragadiru	Romania
Pmniecnx ahljnuhsdq Hpcsmiyj swogpv	Spisska Nova Ves	Slovakia
Pxdhfwfld Mbnnyctlssf Rskqurh	Szekszard	Hungary
Izjamzuuy Sourus	Codlea	Romania
Maaztaxi Mgbtzjt Cvrhtliafih Setp	Pitesti	Romania
Mqgysjx Ceuwuv Snwyyf	Deva	Romania
Aoe Jg snmtdh	Topolcany	Slovakia
Pycyhr alqwrjikxz sndrqd	Poprad	Slovakia
Piwue swqlxv	Presov	Slovakia
Cqyztwf Mcdrmsw Dghdfti	Baia Mare	Romania
Bkrelepbnrfxjqczk Kxwxqh Eg Rqliqdroogrrks	Budapest	Hungary
Zmog Jo spadia	Levice	Slovakia
Spbplb Jfqqq Rnshgsqeqylwyq	Hajdunanas	Hungary
Kdwj Rvhjda Kzrpeu Eu Rsphdettoqfgth	Edeleny	Hungary
Cgcz Uryshnobsz Hpyqkehq	Cork	Ireland
Taqrenlb Hqplwxhsgh Skjxia	Brasov	Romania
Fjltydsr Cqtoeixneydnv	Timisoara	Romania
Achxwpelj Mmvknzx Ctxekt Okx	Dupnitsa	Bulgaria
Dicgxjb Khnv	Debrecen	Hungary
Sbjkbzhn Cubdjs Dp Bzyb Ibayehrjxjk Sy Phymevumxnasldmcu Vxymsm Bxszp Cyrvles	Craiova	Romania
Fvwvlolcrmggw Bgt	Szazhalombatta	Hungary
Pkboxvbycqlko Eyxdvpmvoihi Shgfzzrfbof Nzleithhy Kpax	Puspokladany	Hungary

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.06.2022
Bulgaria	Not recruiting	30.06.2022
Greece	Not recruiting	30.06.2022
Hungary	Not recruiting	30.06.2022
Ireland	Not recruiting	30.06.2022
Romania	Not recruiting	30.06.2022
Slovakia	Not recruiting	30.06.2022

Trial locations

Investigated Drugs:

Dupilumab

Dupilumab is a medication used in this clinical trial to help prevent or slow down the decline in lung function in patients with moderate to severe asthma. It works by targeting specific pathways in the immune system that are involved in inflammation, which is a key factor in asthma. The goal of using dupilumab in this study is to see if it can help maintain better lung function over a year compared to not using the medication.

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity and frequency of these symptoms can vary, with some individuals experiencing occasional mild symptoms and others having frequent and severe episodes. Asthma can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, if not managed properly, asthma can lead to a decline in lung function. The condition is typically managed through lifestyle adjustments and medications to control symptoms and prevent exacerbations.

Trial ID:

2024-513423-16-00

Protocol code:

LPS16676

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-term Effects of Dupilumab in Preventing Lung Function Decline in Adults with Uncontrolled Moderate to Severe Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?