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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline week 4, week 8, week 12
Awards & highlights
FLASH Trial Summary
This trial will test the effectiveness and safety of a new asthma drug, AZD5718, compared to montelukast (a similar drug) and placebo (a fake drug). It will last 12 weeks and include people with moderate to severe uncontrolled asthma.
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.Check my eligibility
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).See study design
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.
FLASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
FLASH Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first CompEx Asthma event
Secondary outcome measures
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 moreSide effects data
From 2013 Phase 3 trial • 220 Patients • NCT018570635%
Protein urine present
100%
80%
60%
40%
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0%
Study treatment Arm
Montelukast
Placebo
FLASH 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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,029 Total Patients Enrolled
328 Trials studying Asthma
638,466 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 4 weeks.I have not taken strong drugs affecting liver enzymes in the last 4 weeks.My weight is between 50 and 100 kg, and my BMI is between 18 and 30.My asthma control score is 1.5 or higher.Your lung function test results in the morning before taking any medication should show that you can exhale a certain amount of air.My lung function, measured by FEV1, is between 40% and 85% of the expected value.I am on birth control pills that contain ethinyl estradiol.I haven't taken high doses of certain cholesterol medications in the last month.You have a serious mental health condition, especially if it involves thoughts of harming yourself, that may affect your safety during the study.I quit smoking or using e-cigarettes more than 6 months ago and smoked less than 10 pack-years.I haven't donated blood or plasma recently.I haven't taken LTRAs like montelukast in the last 2 weeks.My flu and pneumonia shots are up to date according to local guidelines.I have a health condition that is not stable.I have a serious heart condition.I haven't taken any kidney function affecting drugs in the last month.My flu and pneumonia shots are current according to local guidelines.You can do a lung function test that meets specific standards set by the American Thoracic Society and European Respiratory Society.I was diagnosed with asthma over a year ago.You must be able to complete a lung function test that meets specific criteria set by medical organizations.I haven't taken oral steroids in the last 8 weeks or muscle injections in the last 12 weeks.I have had liver issues from zileuton or similar medications before.I have severe liver problems.I do not have active or untreated TB.I have a significant lung condition that is not asthma.I am between 18 and 55 years old and have agreed to participate in this study.I haven't taken any 5-lipoxygenase inhibitors in the last 6 weeks.I weigh at least 40 kg and my BMI is under 35.I had a severe asthma attack within the last 8 weeks.I have severe kidney issues or my kidney function is very low.You are able to do a lung function test called FEV1 according to specific guidelines.I've been on stable asthma medication for at least 3 months.My weight is between 50-120 kg and my BMI is 18-32.I haven't had major surgery in the last 8 weeks and don't plan any during the trial.I have not taken Gemfibrozil in the last 4 weeks.I haven't taken certain asthma/allergy biologic treatments in the last 6 months.You had a serious case of COVID-19 within the last 6 months.I have cancer, but not skin cancer or any cancer treated over 5 years ago.You have a history of using alcohol or drugs, including marijuana.I am currently pregnant or breastfeeding.I haven't received any blood products or immunoglobulin in the last 4 weeks.I have been diagnosed with asthma for at least a year.I haven't had any immunotherapy in the last 6 months, except for ongoing allergy shots started over 4 weeks ago.I've been on a stable asthma treatment for at least 3 months.I have had a severe asthma attack in the last year.I haven't used certain asthma medications like Symbicort or Fostair for 15 days before my first screening.Your breathing test results must show that you can exhale a certain amount of air before taking medication.I have not had recent hepatitis, unexplained jaundice, or been treated for hepatitis B, C, or HIV.I have a recent positive COVID-19 test confirmed by RT-PCR.
Research Study Groups:
This trial has the following groups:- Group 1: Lead-in PK, Part 1 Placebo
- Group 2: Lead-in PK Cohort (Atuliflapon)
- Group 3: Part 1: Atuliflapon
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are currently conducting this research?
"This medical study is accepting patients at 40 sites, with a concentration of clinics in Miami, Bellaire and Tomball. It is prudent to select the closest clinic possible to diminish any necessary travel if you choose to participate."
Answered by AI
Do those under the age of twenty qualify for this experiment?
"This medical trial seeks to include individuals aged 18 years and above, but under 80 years of age."
Answered by AI
What is the total capacity of participants in this trial?
"Affirmative. Clinicaltrials.gov provides verifiable evidence that this trial, which was initially posted on January 27th 2022, is currently recruiting participants. The study seeks 1900 individuals from 40 diverse sites throughout the country."
Answered by AI
Is my profile compatible with the requirements of this research?
"This clinical trial is looking to recruit 1900 individuals, aged 18-80 years old, who have been diagnosed with asthma. To be eligible for the study, patients must weigh between 50 and 100 kg (inclusive), have a Body Mass Index of 18-30kg/m^2 at the first visit, possess acceptable lung function; as per ATS/ERS 2019 acceptability criteria; FEV1 ≥ 70% predicted at both Visit 1 & 2 ,be vaccinated against Influenza or Pneumonia and are compliant with Low Dose ICS + LABA or Medium High dose ICS alone / combined wLABA for 3 months"
Answered by AI
Has recruitment for this medical study been opened?
"Affirmative, the information on clinicaltrials.gov attests that this trial is actively seeking participants. The study was initially posted on January 27th 2022 and underwent a revision as recently as October 21st 2022. It seeks to enroll 1900 patients across 40 different medical centres."
Answered by AI
Could you provide an update on AZD5718's approval status from the FDA?
"An assessment of AZD5718's safety determined it to be a 2 on the scale. This is reflective of this being Phase 2, meaning there are preliminary findings that suggest safety but no evidence supporting its effectiveness yet."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Arizona
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
After having COVID for the fourth time, and pneumonia for the second time (in Nov./Dec. 2023), I my fatigue and asthma symptoms have intensified. I have tried a few different inhalers, as well as been on oral steroids, but have not improved.
PatientReceived 2+ prior treatments
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