What side effects are associated with this type of intervention?

Common treatments for asthma that are similar to Atuliflapon include leukotriene receptor antagonists (e.g., montelukast) and inhaled corticosteroids. Known side effects of leukotriene receptor antagonists can include headache, dizziness, abdominal pain, and, in rare cases, neuropsychiatric events such as agitation, aggression, and depression. Inhaled corticosteroids may cause side effects such as oral thrush, hoarseness, and, with long-term use, potential impacts on growth in children. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of asthma that target the leukotriene pathway or have anti-inflammatory properties. Montelukast and zafirlukast are leukotriene receptor antagonists that help reduce inflammation and bronchoconstriction in asthma patients. Additionally, zileuton, a leukotriene synthesis inhibitor, is another FDA-approved drug that targets the leukotriene pathway. These medications help manage asthma symptoms by reducing inflammation and preventing airway constriction.

What other types of research exist?

Promising novel alternatives to Atuliflapon for asthma treatment in 2024 include biologics such as Dupilumab, which targets the IL-4 and IL-13 pathways, and Tezepelumab, which targets thymic stromal lymphopoietin (TSLP). Both have shown significant efficacy in reducing asthma exacerbations and improving lung function in clinical trials. Additionally, JAK inhibitors like Tofacitinib, which modulate the JAK-STAT signaling pathway, are emerging as potential treatments for severe asthma.

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Atuliflapon for Uncontrolled Asthma (FLASH Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Bodyweight 50 to 100 kg (inclusive) and BMI 18 to 30 kg/m^2 (inclusive) at Visit 1.

General Inclusion Criteria for Part 1 and Part 2: An Asthma Control Questionnaire (ACQ)-6 score ≥ 1.5 at screening Visit 1 and at Visit 3

Must not have

Live or attenuated vaccines within 4 weeks of screening Visit 1

Any clinically significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline week 4, week 8, week 12

Summary

This trial is testing Atuliflapon, a new medication, in adults with moderate to severe uncontrolled asthma. It aims to see if Atuliflapon can better manage asthma symptoms for those who do not respond well to current treatments.

Who is the study for?

Adults with moderate to severe uncontrolled asthma for over a year, able to perform lung function tests, and on stable asthma medication can join. They must have had at least one severe asthma attack in the past year and be vaccinated against flu/pneumonia. Exclusions include recent drug trials, certain medications like high-dose statins or systemic steroids, liver impairment, other significant diseases, current cancer (except some skin cancers), substance abuse history, pregnancy or breastfeeding.

What is being tested?

The trial is testing Atuliflapon's effectiveness and safety compared to a placebo over 12 weeks in adults with uncontrolled asthma. It's randomized (participants are assigned by chance), double-blind (neither participants nor researchers know who gets what treatment) and placebo-controlled (compared against an inactive substance).

What are the potential side effects?

While specific side effects of Atuliflapon aren't listed here, common side effects from similar treatments may include respiratory symptoms like coughing or wheezing, headaches, nausea or vomiting; allergic reactions are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 50 and 100 kg, and my BMI is between 18 and 30.

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My asthma control score is 1.5 or higher.

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My lung function, measured by FEV1, is between 40% and 85% of the expected value.

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I am between 18 and 55 years old and have agreed to participate in this study.

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I weigh at least 40 kg and my BMI is under 35.

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I've been on stable asthma medication for at least 3 months.

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My weight is between 50-120 kg and my BMI is 18-32.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received any live vaccines in the last 4 weeks.

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I have a serious heart condition.

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I haven't taken any kidney function affecting drugs in the last month.

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I haven't taken oral steroids in the last 8 weeks or muscle injections in the last 12 weeks.

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I have had liver issues from zileuton or similar medications before.

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I have severe liver problems.

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I do not have active or untreated TB.

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I have a significant lung condition that is not asthma.

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I have severe kidney issues or my kidney function is very low.

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I haven't had major surgery in the last 8 weeks and don't plan any during the trial.

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I have not taken Gemfibrozil in the last 4 weeks.

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I haven't taken certain asthma/allergy biologic treatments in the last 6 months.

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I am currently pregnant or breastfeeding.

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I haven't used certain asthma medications like Symbicort or Fostair for 15 days before my first screening.

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I have not had recent hepatitis, unexplained jaundice, or been treated for hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline week 4, week 8, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline week 4, week 8, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline week 4, week 8, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first CompEx Asthma event

Secondary study objectives

Change from baseline in Asthma Control Questionnaire 6

Change from baseline in Daily asthma symptom score (total, daytime, and night-time)

Change from baseline in Pre-bronchodilator forced expiratory volume in 1 second

+10 more

Side effects data

From 2013 Phase 3 trial • 220 Patients • NCT01857063

Protein urine present

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 1: AtuliflaponExperimental Treatment1 Intervention

Randomised participants will receive Atuliflapon

Group II: Lead-in PK Cohort (Atuliflapon)Experimental Treatment1 Intervention

Randomised participants will receive Atuliflapon

Group III: Lead-in PK, Part 1 PlaceboPlacebo Group1 Intervention

Randomised participants will receive placebo

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments primarily include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), leukotriene receptor antagonists (LTRAs), and combination therapies. ICS reduce airway inflammation by inhibiting multiple inflammatory pathways, which helps prevent asthma exacerbations. LABAs relax bronchial muscles by stimulating beta-2 adrenergic receptors, providing long-term bronchodilation. LTRAs, like montelukast, block leukotriene receptors, reducing inflammation and bronchoconstriction. Combination therapies often include ICS and LABAs to provide both anti-inflammatory and bronchodilatory effects. Treatments like Atuliflapon, likely a leukotriene pathway inhibitor, are important as they target specific inflammatory mediators, offering an alternative for patients who may not respond well to other treatments.

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.