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

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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
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Provita Sp. z o.o. Katowice Poland
Universitair Medisch Centrum Groningen Groningen The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Marques De Valdecilla Santander Spain
Amphia Hospital Breda The Netherlands
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Brasov Romania
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi Lodz Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Hospital Universitario Virgen De La Victoria Malaga Spain
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Arensia Clinics S.R.L. Bucharest Romania
NZOZ Krak-Medyk Sp. Z o.o Cracow Poland
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo – Badawczy Ostróda Poland
Michał Bogacki – DOBROSTAN Wroclaw Poland
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Synexus Polska Sp. z o.o. Poznan Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Military Medical Academy Pleven Bulgaria
Hospital Universitario Infanta Leonor Madrid Spain
Silmedic Sp. z o.o. Katowice Poland
Opca Bolnica Varazdin Varazdin Croatia
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Leamed s.r.o. Presov Slovakia
Medical Center Teodora EOOD Ruse Bulgaria
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Mclbudn Ccrzoc Hvsd Eefl Sofia Bulgaria
Szcwphymnm Bofprpw Mvkbvc Rijeka Croatia
Hfqbeckc Vrzbjs Xleto Icxvuryiocmzk Benalmadena Spain
Dfyqu Hlznfh Clql Sgaogp Bucharest Romania
Iskrbymej Kyrd Pecs Hungary
Uutcmqbvbh Thsjyocx Hqecvbkn Mbxwxupbazbv Szombathely Hungary
Mdeehvm Csurcz Ejwrnfqpp Omt Sofia Bulgaria
Hijxvfwt of Iynsrfevdc Dclvxvir alq Pemiyafpcd Vbeigm Bbigqg Tkqgvaedr Timisoara Romania
Cbuhksk Mvinjkk dq Phwmatqcdqq Bhmnhkpygnac Meoem Cluj Napoca Romania
Dytfxmbvusaggryakcckfjz Cylowy 2r Skqah Ejho Sofia Bulgaria
Mnxiaey Cyzvsi Spvhqa Deva Romania
Akb Jk stwgzy Topolcany Slovakia
Ucdoekravp Cvyshu Gjnfex Golnik Slovenia
Pkmiwvme Gtfdyfp Pqeenrnstxzqdzc lopy Jjvxkk Nxgipqlnkdxwj Grudziadz Poland
Ouay Btwjkuk Dyl Irk Ppgdmzf Shrpi Sisak Croatia
Gtvwwho Hjuktlwe Zonqp Aup Hrgtevpr Om Cknshhqb Vdyntqks Zabok Croatia
Amcjt Suqjcjyqjz Mpaqfbh Sxjsoitj Sic Bucharest Romania
Ixisxhqwtogm Svvfacfyompfobs Pqncbhoj Llfstast lcwx Kqubteesj Ltl Kielce Poland
Papmzxub Phblekmw Lzkkuhjn &bqvnoz Atuc Simvctgsre Idzewwko Kzsngipm Ksawerow Poland
Dorbpnnycb Cjzokkcfjm Cogbdb 1 Ventlzhkh Ecew Velingrad Bulgaria
Zqcy Jg suekol Levice Slovakia
Ssfmtj Juhbu Rzfzbghsrbwmbo Hajdunanas Hungary
Uwytremdwl Mzrdavfsqnvh Hckbmxrd Fnh Aepiyw Twqdsdcru Ekytfhqeayuh Pbkbbzj Lgvp Plovdiv Bulgaria
Mrrviws Cffbhe Zamftsyy Owi Kozloduy Bulgaria
Ucmmyespib Hjtfvhlo Sdfdp Dul Zagreb Croatia
Tbpwtkdw Hilhslpgyn Smxqjh Brasov Romania
Mgbonmq Ceqweq Svzsymg Sozqs Ejad Sofia Bulgaria
Pjdjdw Pzwmpa Rsqhlvgrpy Srw jh Cracow Poland
Sgnibthr Cyfsrt Dk Pqibqihzdcfxzhqgv Lyfx Dubsoljb Cluj Napoca Romania
Fxydhghg Cdlrsevkwtbxl Timisoara Romania
Evjltosv Guthjnivej Kyyn Godollo Hungary
Mkrfnod Ctccvk Nbp Ravnndxgqyjcyg Ctyhib Elwm Stara Zagora Bulgaria
Mqyz Rgyaxoln Gxhe Berlin Germany
Gkygkyf Iaosszucr Sbkvrt Barcelona Spain
Cpwcbime Hehalfva Dmeaqjy Zagreb Croatia
Cyokqcuin Syo z odju Lublin Poland

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)

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