Bronchial AsthmaPhase 2NCT07324707
Study on the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
A Phase 2 study testing PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days and Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days in people with Bronchial Asthma, run by Anhui Palo Alto Pharmaceuticals, Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days and Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years inclusive, regardless of gender;
- According to the definition in the Chinese "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)," subjects diagnosed with bronchial asthma, including those with an initial diagnosis of asthma, or those diagnosed with asthma during childhood or adolescence with stable condition who have not received long-term treatment but exhibit significantly more pronounced symptoms in adulthood and/or recently compared to the past;
- Pre-randomization, pulmonary function tests show 60% ≤ FEV1% predicted ≤ 85%;
- Any objective test result indicating variable airflow limitation conducted within 1 year prior to screening is positive, or the bronchodilator test during the screening period is positive, i.e., an increase in FEV1 ≥ 12% and an absolute increase in FEV1 ≥ 200 mL 15-30 minutes after inhaling 400 μg salbutamol (if the bronchodilator test result does not meet the positive threshold, a repeat bronchodilator test is allowed within 14 days after the test [excluding the test day]); or the bronchial provocation test is positive, i.e., a decrease in FEV1 ≥ 20% after inhaling a provocant (methacholine or histamine); or the average daily diurnal variability of peak expiratory flow (PEF) (calculated as the sum of daily PEF diurnal variability over 7 consecutive days divided by 7) > 10%;
- Voluntarily sign the informed consent form.
Who cannot join
- Subjects who are unable to correctly use a nebulizer, cannot tolerate nebulized inhalation administration, or fail inhalation administration training;
- Subjects with other pulmonary diseases, including chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, tuberculosis, etc., for which, in the investigator's judgment, asthma remains the dominant condition;
- Coexistence of other clinically significant conditions that may affect lung function, including but not limited to pleural diseases, mediastinal diseases, diaphragmatic disorders, myasthenia, thoracic deformities, etc.;
- History of severe cardiovascular diseases, such as congestive heart failure, coronary artery disease, myocardial infarction, arrhythmia, uncontrolled hypertension (resting seated systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on two or more consecutive measurements), etc., which, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results;
- Subjects with hyperthyroidism, assessed by the investigator as unsuitable for participation in this trial;
- History of severe hematologic, hepatic, psychiatric, renal, or other diseases that, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results;
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- History of malignancy within the past five years (excluding cured cervical intraepithelial neoplasia, thyroid cancer, or basal cell carcinoma of the skin diagnosed and cured within 5 years);
- Subjects who have undergone or are expected to undergo solid organ or bone marrow transplantation within the next year;
- Hypokalemia (serum potassium < 3.5 mmol/L during screening);
- Type I diabetes or poorly controlled Type II diabetes (fasting blood glucose > 11.1 mmol/L during screening);
- Known or pre-randomization examination revealing oral, pharyngeal, or esophageal candidiasis;
- Abnormal liver or kidney function during screening (ALT and/or AST > 2× upper limit of normal; Scr > 1.5× upper limit of normal);
- Positive hepatitis B surface antigen or hepatitis B core antibody with HBV DNA ≥ 2000 IU/mL, positive hepatitis C antibody with HCV RNA ≥ 1000 IU/mL, positive human immunodeficiency virus antibody, or history of acquired immunodeficiency syndrome;
- Known allergy to any component of inhaled corticosteroids or salbutamol preparations;
- Respiratory tract infection, sinus infection, or acute otitis media within 4 weeks before screening or during the run-in period, which, in the investigator's judgment, would lead to changes in asthma treatment or affect the subject's asthma status;
- Asthma exacerbation requiring systemic corticosteroid treatment within 4 weeks before screening or during the run-in period, or asthma requiring oral corticosteroid therapy, or other conditions requiring systemic corticosteroid treatment;
- Use of strong CYP3A4 enzyme inhibitors (e.g., ritonavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, etc.) within 4 weeks before dosing, or need for concomitant use of strong CYP3A4 inhibitors during the trial;
- Smoking cessation < 1 year at screening (including cigarettes, cigars, pipe tobacco, e-cigarettes, etc.), or previous smoking history > 10 pack-years [pack-years = number of packs per day × years of smoking, where 1 pack = 20 cigarettes];
- History of drug abuse, substance abuse, or alcoholism within 2 years before screening [alcoholism defined as average daily alcohol intake > 2 units (1 unit = 360 mL beer, or 45 mL of 40% alcohol liquor, or 150 mL wine)];
- Pregnant or lactating women, or women planning pregnancy during the trial;
- Subjects who have participated in other clinical trials within 1 month before screening;
- Any other reason considered by the investigator to make the subject unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Wei Zuo, 86-15879098337, 11545394@qq.com
About this study
Official title: A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
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.
Read the 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
- Being tested
- PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days, Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA9159 Metered-Dose Inhaler, 120 μg per day for 28 daysDrug
PA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 daysDrug
Fluticasone Propionate Inhaled Aerosol of 200 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| PA9159 120 μg | Experimental | Fifteen subjects will be randomly assigned to receive 120 μg of PA9159 Metered-Dose Inhaler for 28 days. Subjects will be administered one vial of drug Twice a day: In the morning, take 2 puffs . In the evening, take 2 puffs . Receives: Drug: PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days |
| Fluticasone Propionate Inhaled Aerosol 200 μg | Active comparator | Fifteen subjects will be randomly assigned to receive 200 μg of Fluticasone Propionate Inhaled Aerosol for 28 days. Subjects will be administered one vial of drug Twice a day: In the morning, take 2 puffs . In the evening, take 2 puffs . Receives: Drug: Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation 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.
Measured: From pre-dose until 28 days post-dose
Secondary outcomes (7)
Evaluation the change from baseline in pre-dose FEV1 at week 1 and week 2 of treatment.
Measured: 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.
Measured: From pre-dose until 28 days post-dose
Proportion of patients with asthma exacerbations during the treatment period.
Measured: From pre-dose until 28 days post-dose
Proportion and frequency of patients using rescue medication over the 4-week treatment period.
Measured: 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.
Measured: 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.
Measured: From pre-dose until 28 days post-dose
Evaluation the change from baseline in FENO at weeks 2 and 4 of treatment.
Measured: From pre-dose until 28 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Oct 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zuo, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324707
- Sponsor's protocol ID
- PA9159AS-202
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
- ClinicalTrials.gov ID
- NCT07324707
- Acronym / sponsor ID
- PA9159AS-202
- Conditions
- Bronchial Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA9159 120 μg | Experimental | Drug: PA9159 Metered-Dose Inhaler, 120 μg per day for 28 daysFifteen subjects will be randomly assigned to receive 120 μg of PA9159 Metered-Dose Inhaler for 28 days. Subjects will be administered one vial of drug Twice a day: In the morning, take 2 puffs . In the evening, take 2 puffs . |
| Fluticasone Propionate Inhaled Aerosol 200 μg | Active comparator | Drug: Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 daysFifteen subjects will be randomly assigned to receive 200 μg of Fluticasone Propionate Inhaled Aerosol for 28 days. Subjects will be administered one vial of drug Twice a day: In the morning, take 2 puffs . In the evening, take 2 puffs . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 75 years inclusive, regardless of gender;
- According to the definition in the Chinese "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)," subjects diagnosed with bronchial asthma, including those with an initial diagnosis of asthma, or those diagnosed with asthma during childhood or adolescence with stable condition who have not received long-term treatment but exhibit significantly more pronounced symptoms in adulthood and/or recently compared to the past;
- Pre-randomization, pulmonary function tests show 60% ≤ FEV1% predicted ≤ 85%;
- Any objective test result indicating variable airflow limitation conducted within 1 year prior to screening is positive, or the bronchodilator test during the screening period is positive, i.e., an increase in FEV1 ≥ 12% and an absolute increase in FEV1 ≥ 200 mL 15-30 minutes after inhaling 400 μg salbutamol (if the bronchodilator test result does not meet the positive threshold, a repeat bronchodilator test is allowed within 14 days after the test [excluding the test day]); or the bronchial provocation test is positive, i.e., a decrease in FEV1 ≥ 20% after inhaling a provocant (methacholine or histamine); or the average daily diurnal variability of peak expiratory flow (PEF) (calculated as the sum of daily PEF diurnal variability over 7 consecutive days divided by 7) > 10%;
- Voluntarily sign the informed consent form.
Key exclusion criteria (22 listed)
- Subjects who are unable to correctly use a nebulizer, cannot tolerate nebulized inhalation administration, or fail inhalation administration training;
- Subjects with other pulmonary diseases, including chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, tuberculosis, etc., for which, in the investigator's judgment, asthma remains the dominant condition;
- Coexistence of other clinically significant conditions that may affect lung function, including but not limited to pleural diseases, mediastinal diseases, diaphragmatic disorders, myasthenia, thoracic deformities, etc.;
- History of severe cardiovascular diseases, such as congestive heart failure, coronary artery disease, myocardial infarction, arrhythmia, uncontrolled hypertension (resting seated systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on two or more consecutive measurements), etc., which, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results;
- Subjects with hyperthyroidism, assessed by the investigator as unsuitable for participation in this trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA9159 Metered-Dose Inhaler, 120 μg per day for 28 daysPA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days. | Drug | PA9159 120 μg |
| Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 daysFluticasone Propionate Inhaled Aerosol of 200 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days. | Drug | Fluticasone Propionate Inhaled Aerosol 200 μg |
Primary outcome
Evaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment.
Time frame: From pre-dose until 28 days post-dose
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.
7 secondary outcomes
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zuo principal investigator
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days and Fluticasone Propionate Inhaled Aerosol 200 μg per day for 28 days in people with Bronchial Asthma, run by Anhui Palo Alto Pharmaceuticals, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengli Kan (86-15618775927, kanmengli@paloaltopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment. (time frame: From pre-dose until 28 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.