Study on the Effects of Atuliflapon in Adults with Moderate to Severe Uncontrolled Asthma

1 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for asthma, specifically in adults with moderate to severe forms of the condition that are not well controlled. The treatment being tested is a medication called Atuliflapon, which is taken as a tablet once a day. The study will compare the effects of Atuliflapon to a placebo, which is a substance with no active medication, to see how effective and safe Atuliflapon is for people with asthma.

The purpose of the study is to evaluate how well Atuliflapon works in improving asthma symptoms and its safety for patients. Participants in the study will take the medication or placebo for a period of twelve weeks. During this time, they will have regular check-ups to monitor their health and any changes in their asthma symptoms. The study will also involve the use of Salbutamol, a common medication used to relieve asthma symptoms, which participants may use as needed.

Throughout the study, participants will be asked to keep track of their asthma symptoms and any side effects they experience. This information will help researchers understand the potential benefits and risks of Atuliflapon for treating asthma. The study aims to provide valuable insights into whether Atuliflapon can be a new option for people with moderate to severe uncontrolled asthma.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either Atuliflapon or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

Participants undergo initial assessments to establish baseline health metrics. These assessments include lung function tests and other evaluations to ensure eligibility and safety.

2 medication administration

Participants take Atuliflapon or a placebo orally once daily for a duration of twelve weeks. The medication is provided in tablet form.

In addition to the study medication, participants may use Salbutamol as needed for asthma relief. Salbutamol is administered via inhalation.

3 ongoing assessments

Throughout the twelve-week period, participants attend regular visits to monitor their health and the effects of the medication. These visits occur at baseline, week 4, and week 12.

Assessments include lung function tests, symptom questionnaires, and other health evaluations to track changes from the baseline.

4 completion of study

At the end of the twelve-week period, participants undergo final assessments to evaluate the overall efficacy and safety of the treatment.

The study aims to determine the time to the first asthma exacerbation and other clinical efficacy endpoints, such as changes in lung function and symptom scores.

Who Can Join the Study?

  • Must have signed and dated written consent before any study-specific procedures.
  • Must be willing and able to follow study procedures and restrictions.
  • Must be between 18 to 80 years old at the time of signing the consent form.
  • Must have a documented diagnosis of asthma for at least 12 months before the screening.
  • Must have a body weight of at least 40 kg and a Body Mass Index (BMI) less than 35 kg/m2.
  • Must have a morning pre-bronchodilator FEV1 (a lung function test) between 40% and 85% of the predicted value at screening and visit 3.
  • Must have a history of at least one severe asthma exacerbation within one year before screening.
  • Must be treated with low-dose ICS-LABA or medium-high dose ICS alone or in combination with LABA at a stable dose for at least 3 months before screening. ICS-LABA is a combination of inhaled corticosteroids and long-acting beta-agonists used for asthma treatment.
  • Must have an Asthma Control Questionnaire (ACQ-6) score of 1.5 or higher at screening and visit 3. The ACQ-6 is a tool used to measure asthma control.
  • Must be able and willing to comply with the study requirements, including reading, writing, and using electronic devices like eCOA (electronic Clinical Outcome Assessment) and spirometry (a test to measure lung function).
  • Must have at least 80% compliance with usual asthma medication during the run-in period based on daily asthma electronic patient-reported outcomes (ePROs).
  • Must have at least 80% compliance with daily eCOA assessments, which include completing daily ePRO questions and Peak Expiratory Flow (PEF) measurement.
  • For female participants, a negative serum pregnancy test at screening and a negative urine pregnancy test at visit 3 are required.
  • Contraceptive use by female participants should follow local regulations for clinical studies. There are no restrictions for male participants or their female partners.

Who Cannot Join the Study?

  • Having a different type of asthma that is not classified as moderate-to-severe uncontrolled asthma.
  • Being younger than 18 years old or older than 65 years old.
  • Having a medical condition that could interfere with the study or make participation unsafe.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to medications.
  • Using certain medications that could interfere with the study treatment.
  • Having participated in another clinical trial recently.
  • Having a history of substance abuse or alcohol dependency.
  • Being unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo – Badawczy Ostróda Poland
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Leamed s.r.o. Presov Slovakia
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
University Hospital Sveti Duh Zagreb Croatia
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Delta Health Care S.R.L. Bucharest Romania
Hospital Universitario Infanta Leonor Madrid Spain
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Silmedic Sp. z o.o. Katowice Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj Napoca Romania
Infer-Med Kft. Pecs Hungary
Opca Bolnica Varazdin Varazdin Croatia
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Diagnostic-Consultative Center 22 Sofia EOOD Sofia Bulgaria
Theramed Healthcare S.R.L. Brasov Romania
Erzsebet Gondozohaz Kft. Godollo Hungary
Giromed Institute S.L.P. Barcelona Spain
Medical Centre Synexus Sofia EOOD Sofia Bulgaria
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
MECS Research GmbH Berlin Germany
University Teaching Hospital Markusovszky Szombathely Hungary
Medical Center Excelsior OOD Sofia Bulgaria
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Synexus Polska Sp. z o.o. Poznan Poland
Specijalna Bolnica Medico Rijeka Croatia
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Hospital Vithas Xanit Internacional Benalmadena Spain
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Medical Center Teodora EOOD Ruse Bulgaria
Anima Speciality Medical Services SRL Bucharest Romania
Hospital Universitario Virgen De La Victoria Malaga Spain
Centermed Sp. z o.o. Lublin Poland
Zapa Jj s.r.o. Levice Slovakia
Adyytwo Czzzsjm Svyqgt Bucharest Romania
Uzmasqvtswyu Moahyhl Cgxatti Gcokielga Groningen The Netherlands
Hswqklwb Uqwgtaincncea Mkgmopb Dk Vmheymlbig Santander Spain
Cmtexxi Miqkmkf Da Drikrfucxt Se Txweuqien Avsvatvjn Nkyzsl Ssjoua Brasov Romania
Wsajvypkkis Wgevkjyblcigxbtaxlzz Cqcabuj Ognkpjyes I Tocupkaoqtfre Ii Mjusbdkjrfw W Lvgio Lodz Poland
Fyaxymhr Chdrwlzakgfaa Timisoara Romania
Uvrhtpddxw Cechpp Giszjq Golnik Slovenia
Mokhrmr Ciibtc Sgrorj Deva Romania
Gukiuum Huplkyao Zjiwg Aaa Hskgtlva Oe Cqjjmphi Vzodqjek Zabok Croatia
Ohcr Bjhkrlf Dvh Ivr Peogspb Stdhi Sisak Croatia
Aqx Jy sucrin Topolcany Slovakia
Przeonkt Pdkczfbj Lhjqwlwd &dnnkjy Aaxm Szgmwodoeo Ivsqeayw Kbwvccov Ksawerow Poland
Idlsoifjwouf Sucueemvuxpzpfi Pesnpfee Lbnrawwi lhvo Kvfzytamk Lqk Kielce Poland
Chqytig Mlhshdj da Pdnjvufsgjx Bdfjkhmiwylk Mkqin Cluj Napoca Romania
Sjckio Jugxu Rizfzfvmwyxnsy Hajdunanas Hungary
Mwxglm Bldyjcx – Dllmzxcdx Wroclaw Poland
Pqklghw Suo z olon Katowice Poland
Msyhonsh Mcoiwjz Ajxfxve Pleven Bulgaria
Hrwooxke Ugxduholuogvd Hynbjldu Tbvit y Pyyhkq Igbevhik Caatxd dbufphgpsnoyjqfrz (dnnn Badalona Spain
Pfhcmzoi Gfqrzcj Ppmhsomlnvnvcmt lpmo Jbcixl Njnwgylwtkajv Grudziadz Poland
Nrez Kjwedotecx Slf Z ong Cracow Poland
Dhhjurblht Cmzbardnlj Cozhwe 1 Vpmjdkzbb Ecza Velingrad Bulgaria
Cqnoiewx Hbygcain Dqoajzz Zagreb Croatia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
20.04.2023
Croatia Croatia
Not recruiting
20.04.2023
Germany Germany
Not recruiting
20.04.2023
Hungary Hungary
Not recruiting
20.04.2023
Poland Poland
Not recruiting
20.04.2023
Romania Romania
Not recruiting
20.04.2023
Slovakia Slovakia
Not recruiting
20.04.2023
Slovenia Slovenia
Not recruiting
20.04.2023
Spain Spain
Not recruiting
20.04.2023
The Netherlands The Netherlands
Not recruiting
20.04.2023

Trial locations

Investigated drugs:

Atuliflapon is a medication being studied for its potential to help adults with moderate to severe uncontrolled asthma. It is taken by mouth once a day. The goal of the trial is to see how well Atuliflapon works in improving asthma symptoms and to ensure it is safe for use.

Investigated diseases:

Moderate-to-Severe Uncontrolled Asthma – This is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. Individuals with this form of asthma experience frequent symptoms such as wheezing, coughing, shortness of breath, and chest tightness, which are not adequately controlled by standard treatments. The disease progresses with episodes of exacerbations, where symptoms become more severe and may require additional medical intervention. These exacerbations can be triggered by various factors, including allergens, respiratory infections, and environmental irritants. Over time, the persistent inflammation can lead to structural changes in the airways, known as airway remodeling, which may further impact lung function. Managing this condition often involves a combination of medications and lifestyle adjustments to minimize symptoms and prevent exacerbations.

Trial ID:
2023-509243-27-00
Protocol code:
D7552C00001
NCT ID:
NCT05251259
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Testing WIN378 Safety and Effects in Adults with Moderate or Severe Asthma

    Recruiting

    Investigated diseases:
    Bulgaria France Germany Spain Sweden
  • A study to evaluate the effects of KT-621 in adults with moderate to severe eosinophilic asthma

    Recruiting

    Austria Belgium Germany Italy Poland Romania +2