Actively Recruiting
Study on the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
Led by Anhui Palo Alto Pharmaceuticals, Inc. · Updated on 2026-01-07
30
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years inclusive, regardless of gender
- Diagnosed with bronchial asthma as defined by Chinese guidelines, including initial diagnosis or stable childhood/adolescent asthma with recent symptom worsening
- Pre-randomization lung function showing FEV1% predicted between 60% and 85%
- Positive test result for variable airflow limitation within 1 year prior or positive bronchodilator or bronchial provocation test during screening
- Voluntarily signed informed consent form
You will not qualify if you...
- Unable to correctly use or tolerate nebulized inhalation or fail inhalation administration training
- Having other lung diseases like COPD, bronchiectasis, pulmonary fibrosis, tuberculosis where asthma is not dominant
- Other significant conditions affecting lung function such as pleural diseases, mediastinal diseases, diaphragmatic disorders, myasthenia, thoracic deformities
- History of severe cardiovascular diseases including congestive heart failure, coronary artery disease, myocardial infarction, arrhythmia, or uncontrolled hypertension
- Hyperthyroidism deemed unsuitable by investigator
- Severe hematologic, hepatic, psychiatric, renal, or other diseases affecting safety or data interpretation
- History of malignancy within past 5 years except certain cured cancers
- Undergoing or expected transplantation within next year
- Hypokalemia during screening
- Type I diabetes or poorly controlled Type II diabetes
- Known or detected oral, pharyngeal, or esophageal candidiasis
- Abnormal liver or kidney function during screening
- Positive tests for hepatitis B or C, HIV, or AIDS history
- Allergy to inhaled corticosteroids or salbutamol
- Respiratory or sinus infection, or acute otitis media within 4 weeks before screening
- Asthma exacerbation needing systemic corticosteroids within 4 weeks before screening or during run-in
- Use of strong CYP3A4 enzyme inhibitors within 4 weeks before dosing or during trial
- Smoking cessation less than 1 year or history of heavy smoking
- History of drug, substance abuse, or alcoholism within 2 years
- Pregnant, lactating, or planning pregnancy during trial
- Participation in other clinical trials within 1 month before screening
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
M
Mengli Kan
CONTACT
C
Chunping Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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