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AZD1402 for Asthma (APATURA Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 until day 56 ± 4
Awards & highlights

APATURA Trial Summary

This trial is testing a new drug to see if it is safe and effective for people with asthma who are uncontrolled on medium-to-high dose inhaled corticosteroids and long acting beta agonists. The study will last for 3.5 months and will be conducted at multiple centers.

Eligible Conditions
  • Asthma

APATURA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 until day 56 ± 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 until day 56 ± 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of participants with adverse events (AEs)
Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4
Secondary outcome measures
Part 1 and Part 2: Accumulation ratio for AUCτ (Rac AUC)
Part 1 and Part 2: Accumulation ratio for Cmax (Rac Cmax)
Part 1 and Part 2: Antidrug antibodies (ADA) titers testing for all ADA-positive samples as measure of immunogenicity
+20 more

APATURA Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 1: AZD1402 Dose 3Experimental Treatment3 Interventions
Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.
Group II: Part 1 and Part 2: AZD1402 Dose 2Experimental Treatment3 Interventions
Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.
Group III: Part 1 and Part 2: AZD1402 Dose 1Experimental Treatment3 Interventions
Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.
Group IV: Part 1 and Part 2: PlaceboPlacebo Group3 Interventions
Randomised participants will receive oral inhalation of matching placebo via DPI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD1402
2019
Completed Phase 1
~20

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,620,078 Total Patients Enrolled
333 Trials studying Asthma
642,907 Patients Enrolled for Asthma
~17 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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