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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
PA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
Fluticasone Propionate Inhaled Aerosol of 200 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGEvaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment.
After the subject takes a deep breath as much as possible, the volume of air that can be exhaled in the first second when exhaling with maximum force and speed. This is one of the most core indicators in pulmonary function tests, directly reflecting the patency of the airways (especially the large airways). A lower FEV₁ value indicates more severe airway obstruction. Therefore, the difference is calculated as the value after 28 days of treatment minus the baseline value. A larger upward change indicates more significant symptom improvement.
Time frame: From pre-dose until 28 days post-dose
Evaluation the change from baseline in pre-dose FEV1 at week 1 and week 2 of treatment.
Time frame: From pre-dose until 14 days post-dose
Evaluation the change from baseline in pre-dose morning and evening peak expiratory flow (PEF) at weeks 1, 2, and 4 of treatment.
Time frame: From pre-dose until 28 days post-dose
Proportion of patients with asthma exacerbations during the treatment period.
Time frame: From pre-dose until 28 days post-dose
Proportion and frequency of patients using rescue medication over the 4-week treatment period.
Time frame: From pre-dose until 28 days post-dose
Evaluation the change from baseline in the Asthma Control Test (ACT) score after 4 weeks of treatment.
Time frame: From pre-dose until 28 days post-dose
Evaluation the change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score at weeks 2 and 4 of treatment.
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Time frame: From pre-dose until 28 days post-dose
Evaluation the change from baseline in FENO at weeks 2 and 4 of treatment.
Time frame: From pre-dose until 28 days post-dose