Study on RPT193 for Adults with Moderate-to-Severe Asthma Partially Controlled by Inhaled Corticosteroids and Long-Acting Beta 2 Agonists

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for adults with moderate-to-severe asthma, specifically a type known as T2-high asthma. This type of asthma is characterized by certain immune responses in the body. The study will evaluate a medication called RPT193, which is taken as a tablet. Participants in the study will either receive RPT193 or a placebo, which is a tablet without active ingredients. The purpose of the study is to assess how well RPT193 works in preventing the worsening of asthma symptoms in people who are already using inhaled corticosteroids and long-acting beta 2 agonists, which are common treatments for asthma.

During the study, participants will take RPT193 or a placebo for a period of 14 weeks. The study will monitor how the treatment affects asthma control, including any changes in breathing tests and the need for additional asthma medication. Participants will have regular check-ups to track their progress and any side effects they might experience. The study aims to provide more information on the safety and effectiveness of RPT193 as a potential new treatment option for asthma.

In addition to RPT193, the study involves other medications commonly used for asthma, such as Fluticasone Propionate, Salmeterol, and Salbutamol Sulfate. These medications are typically administered through inhalers and are part of the standard treatment for asthma. The study will help determine if adding RPT193 to these existing treatments can offer better control of asthma symptoms. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the treatment’s impact.

1 joining the study

Upon joining the study, the participant will begin by taking a medication called RPT193. This is administered in the form of a tablet.

The dosage for RPT193 is 400 mg, and it is taken orally.

2 initial treatment phase

Participants will continue their existing inhaled corticosteroid and long-acting beta 2 agonist therapy. This includes medications such as Flixotide and Seretide Diskus, which are administered via inhalation.

The inhalation medications are used to help manage asthma symptoms and are taken as prescribed by the healthcare provider.

3 monitoring and assessment

Throughout the 14-week study period, participants will be monitored for any changes in asthma control. This includes tracking the frequency of reliever inhaler use and any asthma exacerbations.

Participants will have regular assessments to measure lung function, including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).

4 completion of treatment

At the end of the 14-week period, participants will complete their course of RPT193 and continue with their regular asthma management plan as advised by their healthcare provider.

Final assessments will be conducted to evaluate the overall effect of the treatment on asthma control and lung function.

Who Can Join the Study?

Must be a male or female adult aged between 18 and 75 years old.
Women who can have children must have a negative pregnancy test before starting the study and at the beginning of the study.
Women who can have children and are sexually active must agree to use a very effective birth control method from at least 4 weeks before starting the study until at least 30 days after the last dose of the study medication. These methods include hormonal birth control, devices placed inside the uterus, a partner who has had a vasectomy, or using two barrier methods like a condom with a cervical cap.
Women must agree not to undergo egg retrieval during the study and for 30 days after the last dose of the study medication.
Men who are sexually active must agree to use one of the highly effective birth control methods from the start of the study until at least 90 days after the last dose of the study medication. If their female partner uses hormonal birth control, she should start at least 4 weeks before the study and continue until at least 90 days after the last dose.
Men must agree not to donate sperm during the study and for 90 days after the last dose of the study medication.
Must be willing to participate and able to give informed consent before any study-related procedures.
Must have been diagnosed with asthma for at least 6 months according to GINA guidelines.
Must have a body mass index (BMI) of at least 18 kg/m². BMI is a measure of body fat based on height and weight.
Must have a pre-bronchodilator FEV1 (a measure of lung function) between 40% and 80% at the screening visit and between 40% and 85% at the start of the study. FEV1 is the amount of air you can forcefully exhale in one second.
Must show evidence of reversible airway obstruction, which means the lungs can improve after using medication. This is shown by a 12% and 200 mL increase in FEV1 after using an inhaler or having a history of such improvement within the last year.
Must have a history of either using a systemic corticosteroid (a type of medication) for at least 3 days or being hospitalized or visiting the emergency room for worsening asthma in the past year.
Must be on medium- or high-dose inhaled corticosteroid therapy combined with a long-acting beta 2 agonist, with a stable dose for 8 weeks before the study and at the start of the study.
Must have a questionnaire score between 1.5 and 3.5 at screening and between 1.25 and 3.5 at the start of the study.
Must have an absolute eosinophil count of at least 300/µL within the last 6 months or a FeNO (a measure of airway inflammation) of at least 25 parts per billion at screening.

Who Cannot Join the Study?

Patients who do not have a diagnosis of asthma.
Patients who are not adults. This means individuals who are not yet 18 years old.
Patients who do not have T2-high partially controlled asthma. This is a type of asthma that is not fully managed even with medication.
Patients who are not currently using inhaled corticosteroids (ICS). These are medications that help reduce inflammation in the airways.
Patients who are not using long-acting beta 2 agonists (LABA). These are medications that help relax muscles in the airways to improve breathing.
Patients who are not able to follow the study procedures for 14 weeks.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
MUDr. Jaroslav Mares – ordinace pro TBC a respiracní nemoci	Strakonice	Czechia

Other Sites

Site Name	City	Country
Medical Center Zdrave-1 OOD	Kozloduy	Bulgaria
Medical Center Research Expert OOD	Varna	Bulgaria
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Medical Center Excelsior OOD	Sofia	Bulgaria
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Alergologia Plus Sp. z o.o.	Poznan	Poland
Ip Clinic Sp. z o.o.	Lodz	Poland
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Lekarze Specjalisci J. Malolepszy I Partnerzy	Wroclaw	Poland
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse	Ruse	Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD	Vratsa	Bulgaria
Centrum Diagnostyczno Terapeutyczne Medicus Sp. z o.o.	Lubin	Poland
Plicni Stredisko Teplice s.r.o.	Teplice	Czechia
MUDr. Ilona Pavlisova s.r.o.	Miroslav	Czechia
GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnei Poradnie Specjalistyczne	Cracow	Poland
MUDr. I. Cierna Peterova s.r.o.	Brandys Nad Labem	Czechia
Pneumologie Varnsdorf s.r.o.	Liberec	Czechia
Tzbrwxbx Sjw z otpp	Piotrkow Trybunalski	Poland
Mpufxm Bdcidse – Dastqpnod	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	16.09.2023
Czechia	Not recruiting	16.09.2023
Poland	Not recruiting	16.09.2023

Trial locations

Investigated drugs:

RPT193 is an investigational medication being studied for its potential to help adults with moderate-to-severe asthma. This medication is being tested to see if it can improve asthma control in patients who are already using inhaled corticosteroids and long-acting beta 2 agonists. The goal is to determine if RPT193 can reduce the frequency or severity of asthma symptoms over a period of 14 weeks.

Investigated diseases:

Asthma

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 condition can vary in severity and may be triggered by allergens, exercise, cold air, or stress. Asthma progresses through episodes or attacks, where symptoms worsen and may require medical intervention. Over time, if not managed properly, asthma can lead to persistent airway changes and reduced lung function. The condition is often managed with medications to control inflammation and relieve symptoms.

Trial ID:

2022-502854-16-00

Protocol code:

RPT193-03

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on RPT193 for Adults with Moderate-to-Severe Asthma Partially Controlled by Inhaled Corticosteroids and Long-Acting Beta 2 Agonists

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?