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Corticosteroid
AZD8630 for Uncontrolled Asthma (Levante Trial)
Phase 2
Recruiting
Led By Njira Lugogo
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be 18 to 80 years of age at the time of signing the ICF
Documented physician diagnosis of asthma for at least 12 months
Must not have
Clinically important pulmonary disease other than asthma
Evidence of active TB or current treatment for TB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing different doses of AZD8630 delivered through an inhaler in adults with uncontrolled asthma. The participants are already taking medium to high doses of inhaled corticosteroids and
Who is the study for?
Adults with uncontrolled asthma who are still having issues despite using medium to high doses of inhaled steroids and long-acting inhalers. They must have had at least one severe asthma attack in the past year.
What is being tested?
The trial is testing different doses of a new drug called AZD8630, given through an inhaler, to see if it's effective and safe for people whose asthma isn't well-controlled by their current medications.
What are the potential side effects?
Potential side effects aren't specified here, but common ones for new asthma treatments can include throat irritation, headache, coughing, or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I have been diagnosed with asthma for over a year.
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My BMI is between 18 and 37.
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I have had severe worsening of my condition in the last year.
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I am currently on a medium or high dose of inhaled corticosteroids with LABA.
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I am not pregnant or breastfeeding.
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I am a male and will use birth control with my partner.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant lung condition that is not asthma.
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I do not have active tuberculosis nor am I being treated for it.
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I have had recent heart problems or procedures.
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I have a history of hepatitis B, C, or HIV.
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I do not have a heart condition like long QT syndrome or uncontrolled irregular heartbeat.
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I have cancer that cannot be removed with surgery.
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I have a history of severe asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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
ACQ-6
AQLQ12+
FeNO
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD8630 dose CExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose C
Group II: AZD8630 dose BExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose B
Group III: AZD8630 dose AExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose A
Group IV: PlaceboPlacebo Group2 Interventions
Inhaled placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD8630
2021
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,095 Total Patients Enrolled
351 Trials studying Asthma
654,785 Patients Enrolled for Asthma
Njira LugogoPrincipal InvestigatorUniveristy of Michigan Hospital, Ann Arbor, MI, US