NCT07324707

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Anhui Palo Alto Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Single-Center, randomized, Open-Label, Active-controlled clinical trial. Subjects of 30 with bronchial asthma are planned to be included in this study. With a ratio of 1: 1 to be randomized allocated to receive PA9159 Inhaler 120 μg, or Fluticasone Propionate Inhalation Aerosol, with 15 subjects in each group. The duration of this study is approximately 42 days, including screening, baseline, treatment observation, and follow-up.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	PA9159 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.
DRUG	Fluticasone 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.

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: China