RecruitingPhase 2NCT07326995

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

60 participants

Start Date

Feb 24, 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 Inhalation Aerosol in patients with bronchial asthma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an inhaled medication called PA9159 to see if it safely and effectively treats adults with bronchial asthma. Researchers want to evaluate how well the drug controls asthma symptoms and whether it is a good treatment option. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with bronchial asthma, either recently or in childhood with symptoms worsening in adulthood - Your lung function tests show moderate airflow limitation (FEV1 between 60% and 85% of expected) - Your breathing significantly improves after using a bronchodilator inhaler, or you have a positive provocation test for asthma - You are willing to sign the informed consent form **You may NOT be eligible if...** - You are unable to use an inhaler correctly - You have other significant lung conditions - You have conditions that would make participation unsafe (specific exclusions were not fully listed) 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, 60 μg per day for 28 days

PA9159 of 60 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.

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.

DRUGPA9159 Metered-Dose Inhaler, 240 μg per day for 28 days

PA9159 of 240 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.

DRUGPlacebo Metered-Dose Inhaler without PA9159, Twice daily for 28 days

Placebo 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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NCT07326995


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