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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

14 criteria

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 trial?

9 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amphia Hospital
Verified
Breda, The Netherlands
Catharina Ziekenhuis Stichting
Verified
Eindhoven, The Netherlands
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland

Trial locations

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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.

What is already known about the treatment

Atuliflapon – This medication is administered orally once daily and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe uncontrolled asthma. It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication for Atuliflapon is to help manage asthma symptoms that are not well-controlled by existing treatments. At the molecular level, Atuliflapon works by targeting specific pathways involved in inflammation, potentially reducing airway inflammation and improving breathing. It is classified pharmacologically as an anti-inflammatory agent.

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.