RecruitingPhase 2NCT07324707

Study on the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma

A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma


Sponsor

Anhui Palo Alto Pharmaceuticals, Inc.

Enrollment

30 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

PA9159 is a highly potent novel corticosteroid. The purpose of this study is to evaluate the safety, efficacy and characteristics of population pharmacokinetics of multiple dosing of PA9159 Inhaler in patients with bronchial asthma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new inhaled aerosol medication called PA9159 for the treatment of asthma in adults. It is looking at whether this drug is safe and effective at improving lung function and controlling asthma symptoms. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with asthma (either newly or as a childhood diagnosis that has worsened in adulthood) - Your lung function test shows moderate impairment (FEV1 60–85% of predicted) - You have a positive bronchodilator response (your breathing improves significantly after inhaling a rescue inhaler) or a positive bronchial challenge test **You may NOT be eligible if...** - You are unable to use an inhaler or nebulizer correctly - You have another lung condition such as COPD, bronchiectasis, or pulmonary fibrosis - You are pregnant or breastfeeding - You have other serious health conditions that the investigator determines make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPA9159 Metered-Dose Inhaler, 120 μg per day for 28 days

PA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.

DRUGFluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days

Fluticasone Propionate Inhaled Aerosol of 200 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT07324707


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