Actively Recruiting
Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
Led by Anhui Palo Alto Pharmaceuticals, Inc. · Updated on 2026-01-08
60
Participants Needed
1
Research Sites
52 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 Inhalation Aerosol in patients with bronchial asthma.
CONDITIONS
Official Title
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 according to Chinese guidelines, including initial diagnosis or stable asthma from childhood/adolescence with recent symptom worsening
- Pre-randomization pulmonary function test showing 60% to 85% predicted FEV1
- Positive objective test indicating variable airflow limitation within 1 year before screening or positive bronchodilator test during screening
- Voluntarily sign the informed consent form
You will not qualify if you...
- Unable to correctly use a nebulizer or tolerate nebulized inhalation or fail inhalation training
- Other pulmonary diseases where asthma is not dominant (e.g., COPD, bronchiectasis, pulmonary fibrosis, tuberculosis)
- Other significant conditions affecting lung function (pleural, mediastinal, diaphragmatic diseases, myasthenia, thoracic deformities)
- Severe cardiovascular diseases or uncontrolled hypertension
- Hyperthyroidism deemed unsuitable by investigator
- Severe hematologic, hepatic, psychiatric, renal, or other diseases affecting risk or study interpretation
- History of malignancy within 5 years (except certain cured cancers)
- Organ or bone marrow transplant planned or done within next year
- Hypokalemia (serum potassium < 3.5 mmol/L)
- Type I diabetes or poorly controlled Type II diabetes (fasting glucose > 11.1 mmol/L)
- Oral, pharyngeal, or esophageal candidiasis
- Abnormal liver or kidney function (ALT/AST > 2× upper limit, Scr > 1.5× upper limit)
- Positive hepatitis B or C with high viral load, HIV positive, or AIDS history
- Allergy to inhaled corticosteroids or salbutamol
- Recent respiratory or sinus infection or acute otitis media within 4 weeks
- Asthma exacerbation requiring systemic corticosteroids within 4 weeks or ongoing corticosteroid treatment
- Use or need of strong CYP3A4 inhibitors within 4 weeks before dosing or during the trial
- Smoking cessation less than 1 year ago or smoking history over 10 pack-years
- 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
- Any other investigator-determined reasons for unsuitability
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here