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Corticosteroid

AZD8630 dose B for Asthma (Levante Trial)

Phase 2
Waitlist Available
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
1. Patient must be 18 to 80 years of age inclusive, at the time of signing the ICF
1. Post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL within 5 years prior to Visit 1, or 2. PEF average daily variability \> 10% over a 2-week period within 5 years prior to Visit 1, or 3. Variability of FEV1 \> 12% and 200 mL between any 2 clinical visits within 5 years prior to Visit 1, or 4. Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of methacholine or ≥ 15% with standardised hyperventilation, hypertonic saline, or mannitol challenge, or 5. Positive exercise challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 of \> 10% and \> 200 mL from pre-challenge, or 6. Significant increase in lung function after 4 weeks of anti-inflammatory treatment with ICS-containing treatment (GINA 2023) within 5 years prior to Visit 1, defined as an increase in FEV1 \> 12% and 200 mL (or PEF by \>20%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) and who have had ≥ 1 documented severe asthma exacerbation in the 12 months prior to enrolment.

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks 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

Trial 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
4,331 Previous Clinical Trials
288,639,569 Total Patients Enrolled
341 Trials studying Asthma
654,427 Patients Enrolled for Asthma
Njira LugogoPrincipal InvestigatorUniveristy of Michigan Hospital, Ann Arbor, MI, US
~344 spots leftby May 2025
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