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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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,349 Total Patients Enrolled
328 Trials studying Asthma
639,562 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for this research project?

"As indicated on clinicaltrials.gov, enrollment for this medical trial is still taking place. The study was initially announced the 12th of March 2021 and its details were updated last October 21st 2022."

Answered by AI

What is the cap on participants involved in this research endeavor?

"Affirmative. According to the details posted on clinicaltrials.gov, this trial is still recruiting participants and was first listed on March 12th 2021. As of October 21st 2022, 225 patients are needed from a single medical site for the study's completion."

Answered by AI

Who are the optimal candidates for participation in this experiment?

"The clinical trial is seeking 225 participants who have been diagnosed with asthma, and are between the ages of 18-75."

Answered by AI

Has the FDA sanctioned AZD1402 for use?

"AZD1402's safety has been partially established in clinical trials, thus it was assessed a 2 on our team's 1-3 scale. No efficacy data is available for this treatment yet."

Answered by AI

Is the age restriction for this experiment limited to those under 30 years of age?

"This medical trial is actively seeking out individuals aged 18 and older, up to the age of 75."

Answered by AI

What are the core objectives of this experiment?

"In accordance with the information provided by AstraZeneca, this trial will assess two primary outcomes across a Baseline and Week 4 interval: number of participants experiencing adverse events (AEs) as well as proportion of patients whose ACQ 6 score decreases 0.5 or more from baseline to Week 4. Furthermore, maximum observed plasma concentration divided by dose administered (Dose normalised Cmax) is also being investigated in order to understand the pharmacokinetics profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants). These metrics are expected to provide"

Answered by AI
~18 spots leftby Mar 2025