Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids

(APATURA Trial)

Recruiting at 50 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: ICS-LABA

Must not be taking: Systemic corticosteroids, Monoclonal antibodies

Disqualifiers: Pregnancy, Pulmonary disease, COVID-19, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to continue their current asthma medications, specifically medium-to-high dose inhaled corticosteroids (ICS) with long-acting beta agonists (LABA), at a stable dose before and during the study. If you are taking additional asthma medications, they must also be stable before and during the study.

Eligibility Criteria

Inclusion Criteria

Participants who are able to perform acceptable pulmonary function testing for FEV1.

Participants who are able to demonstrate the ability to use the study inhalation device properly.

Participants who have a documented clinical diagnosis of asthma for ≥ 12 months before Visit 1.

Exclusion Criteria

Any clinically important ECG abnormalities.

You have had three or more severe asthma attacks in the past.

High risk of infection suggesting abnormal immune function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a run-in period to stabilize their condition before treatment

4 weeks

Treatment

Participants receive inhaled AZD1402 or placebo for efficacy and safety assessment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD1402
• ICS-LABA combination
• Placebo
• Short acting beta agonist (SABA)

Participant Groups

Group I: Part 1: AZD1402 Dose 3 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.

Group II: Part 1 and Part 2: AZD1402 Dose 2 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.

Group III: Part 1 and Part 2: AZD1402 Dose 1 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.

Group IV: Part 1 and Part 2: Placebo Placebo Group 3 Interventions

Randomised participants will receive oral inhalation of matching placebo via DPI.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology