Atuliflapon

Clinical trials are studying Atuliflapon in adults with moderate to severe uncontrolled asthma. These studies look at whether it is effective and safe compared with placebo, and they measure outcomes such as time to the first asthma worsening event.

Table of Contents

Trial overview

The listed study of Atuliflapon was a Phase 2 trial in adults with moderate to severe uncontrolled asthma.[1] The study was designed to assess both efficacy and safety compared with placebo, which is an inactive treatment.[1]

Study design and treatment groups

This was a randomised, double-blind, placebo-controlled study.[1] Randomised means participants were assigned by chance to study groups, double-blind means neither the participants nor the study team knew who received which treatment, and placebo-controlled means results were compared with an inactive treatment group.[1]

The interventions listed were Atuliflapon given by mouth once daily for twelve weeks, salbutamol by inhalation, and placebo to Atuliflapon.[1] Salbutamol was listed as an intervention in the trial record, but the brief summary focused on Atuliflapon versus placebo for the main comparison.[1]

Who could join the study

The target population was adult participants with moderate to severe uncontrolled asthma.[1] The trial record does not give more detailed entry rules in the source provided, so the exact participation criteria are not available here.[1]

What was measured

The main outcome was time to first CompEx Asthma event.[1] This means the study measured how long it took before the first asthma worsening event happened during the trial.[1] The brief summary says the study aimed to evaluate the clinical efficacy of Atuliflapon compared with placebo in adults with moderate to severe uncontrolled asthma.[1]

Trial status and size

The study status was Completed.[1] The enrollment number was 879, which means 879 people were planned or included in the trial record as the study size.[1]

What this means for patients

Based on the available trial record, Atuliflapon has been tested in a controlled research setting for adults whose asthma was not well controlled.[1] The study design was built to compare outcomes fairly against placebo, which helps researchers judge whether the treatment may make a difference.[1] Because only one trial record is provided here, this article reflects that single study and does not include results beyond the trial status and design details.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05251259 Phase 2 Moderate to severe uncontrolled asthma Completed 879

Ongoing Clinical Trials on Atuliflapon

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

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary The Netherlands Poland +4

Glossary

  • Asthma: A long-term lung condition that can cause wheezing, coughing, chest tightness, and trouble breathing.
  • Moderate to severe: A description of how serious a condition is. Moderate to severe asthma means symptoms are more troublesome and may be harder to control.
  • Uncontrolled asthma: Asthma that is not kept well under control, so symptoms or flare-ups still happen.
  • Phase 2: A stage of clinical research that looks more closely at whether a treatment may work and continues to check safety.
  • Randomised: Participants are put into study groups by chance, not by choice, to make results fairer.
  • Double-blind: A study design where neither the participants nor the study team know who is receiving the study treatment.
  • Placebo: An inactive treatment that looks like the study treatment but does not have the active study medicine.
  • Interventional study: A trial where researchers give a treatment or other intervention and then measure the results.
  • Primary outcome: The main result the trial is designed to measure.
  • CompEx Asthma event: A study-defined asthma worsening event used to measure how asthma changes during the trial.

References