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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
Summary
This trial tests a new inhaled medication, AZD1402, for adults with asthma that isn't well-controlled by their current treatments. The medication is designed to be inhaled directly into the lungs to help improve breathing and reduce symptoms.
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 until day 56 ± 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 until day 56 ± 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Number of participants with adverse events (AEs)
Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4
Secondary study objectives
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 moreTrial 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
4,388 Previous Clinical Trials
289,109,701 Total Patients Enrolled
347 Trials studying Asthma
661,397 Patients Enrolled for Asthma
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