Asthma (Diagnosis)Phase 3NCT07768891
Beclometasone Dipropionate and Formoterol Inhalation Aerosol for Asthma
A Phase 3 study testing Beclometasone Dipropionate and Formoterol Inhalation Aerosol and FOSTER® in people with Asthma (Diagnosis), run by Lunan Better Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Beclometasone Dipropionate and Formoterol Inhalation Aerosol and FOSTER®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to Jun 2028
- Phase
- Phase 3
- 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
- Male or female aged ≥18 and ≤75 years.
- Clinically diagnosed with bronchial asthma for at least 3 months at screening (with traceable diagnostic evidence and medical records), and the diagnosis has been confirmed according to the Guidelines for the Prevention and Management of Bronchial Asthma, meeting the following criteria:
- Positive objective test for variable airflow limitation (i.e., meeting any one of the following): (i) Positive bronchodilator reversibility test (i.e., an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from pre-bronchodilator values after inhalation of a bronchodilator; or an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from baseline after 4 weeks of anti-inflammatory therapy with an inhaled corticosteroid, excluding respiratory tract infections); or (ii) Positive bronchial provocation test: commonly using methacholine or histamine as the inhaled provocative agent, with a positive result defined as a ≥20% decrease in FEV₁ after inhalation, indicating airway hyperresponsiveness. (A positive result from any confirmed objective test for variable airflow limitation performed within 1 year prior to signing the ICF is acceptable; if not available, a positive bronchial provocation or bronchodilator reversibility test must be met at screening.) b) Pulmonary function test: FEV₁ ≥40% of predicted value.
- Within at least 4 weeks prior to signing the ICF, the subject has been on a stable daily dose of an inhaled corticosteroid (ICS) with "as-needed" short-acting β₂-agonist (SABA) use but asthma is not well controlled (ACQ-5 ≥1.00), OR has been on a stable daily dose of an ICS plus a long-acting β₂-agonist (LABA) and asthma is well controlled (ACQ-5 <1.00).
- Subjects who use SABA or other reliever medications as needed before screening may be enrolled only if the investigator assesses that they can be switched to the unified rescue medication provided in this study.
- Willing and able to comply with the protocol requirements and the investigator's instructions for pulmonary function tests, and, after training, able to correctly use the pressurized metered-dose inhaler (pMDI), peak flow meter, and complete the diary card records.
- Willing to voluntarily participate in this study and sign the informed consent form after full informed consent.
Who cannot join
- Have intermittent asthma or asthma that occurs only upon occasional exposure to allergens or chemical sensitizers.
- Have a history of life-threatening asthma (e.g., brittle asthma, admission to the intensive care unit due to an acute asthma exacerbation) within 1 year prior to screening.
- Have other respiratory system diseases, including but not limited to allergic bronchopulmonary aspergillosis (ABPA), active tuberculosis, pneumonia, pneumothorax, idiopathic pulmonary fibrosis, clinically significant atelectasis, chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia, chronic bronchitis, or other significant pulmonary abnormalities other than asthma (such as cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency), and are considered by the investigator to be unsuitable for participation in this clinical study.
- Have a respiratory tract infection of non-viral etiology, sinusitis, or otitis media within 4 weeks prior to screening.
- Have a history of severe cardiovascular or cerebrovascular diseases, such as congestive heart failure of New York Heart Association (NYHA) class ≥II, unstable angina, coronary heart disease, myocardial infarction, stroke, etc., within 6 months prior to screening; have a prolonged QTc interval (QTc >450 ms for males or >470 ms for females, corrected using Fridericia's formula) or have ECG abnormalities that are assessed by the investigator as clinically significant and requiring pharmacological treatment; or have poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after adequate treatment).
- Have oral candidiasis identified at screening.
Show all 19Show fewer
- Have laboratory test results meeting any of the following criteria: Liver function: alanine aminotransferase (ALT) >2×ULN and/or aspartate aminotransferase (AST) >2×ULN, and total bilirubin (TBIL) >2×ULN; Renal function: serum creatinine >1.5×ULN; Fasting blood glucose >10 mmol/L or glycated hemoglobin (HbA1c) ≥8.0%; Serum potassium <3.5 mmol/L.
- Have received biological targeted therapy (including anti-IgE monoclonal antibodies such as omalizumab, anti-IL-5 monoclonal antibodies such as mepolizumab, anti-IL-5 receptor monoclonal antibodies such as benralizumab, or anti-IL-4 receptor monoclonal antibodies such as dupilumab) within 5 half-lives prior to entry into the run-in period.
- Have experienced an asthma exacerbation requiring systemic corticosteroid treatment or have required oral corticosteroid therapy within 4 weeks prior to screening, or have other diseases that require long-term oral or intravenous corticosteroid therapy.
- Have used beta-blockers (including eye drops), quinidine, disopyramide, procainamide, phenothiazines, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or any other medications that may prolong the QTc interval and increase the risk of ventricular arrhythmias within 4 weeks prior to screening.
- Have a history of drug abuse or alcohol abuse within 1 year prior to screening.
- Are current smokers; have a smoking history of ≥10 pack-years (1 pack = 20 cigarettes); for those with a smoking history of <10 pack-years, they must have stopped smoking for at least 6 months to be eligible for the study.
- Have received treatment with any other investigational drug or device in another clinical trial within 3 months prior to screening.
- Have a known intolerance to or contraindication to beta₂-agonists and/or inhaled corticosteroids, or are allergic to any component of the investigational products.
- Are pregnant or breastfeeding; or are women of childbearing potential, or male subjects with partners of childbearing potential, who do not agree to use medically recognized effective contraceptive measures (such as an intrauterine device or condom) during the study and for 6 months after the last dose of the investigational product.
- Meet any of the following conditions prior to randomization:
- Run-in period compliance <80% or >120%;
- Have an asthma exacerbation during the run-in period (including asthma-related serious adverse events, asthma worsening leading to hospitalization or emergency treatment, unscheduled visits resulting in changes in treatment, etc.);
- Are considered by the investigator to be unsuitable for randomization.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Meiling Jin, 021-31587861, MLjin118@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Phase III Clinical Study Comparing the Efficacy and Safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol Versus FOSTER® in Patients With Asthma.
A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Beclometasone Dipropionate and Formoterol Inhalation Aerosol, FOSTER®
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclometasone Dipropionate and Formoterol Inhalation AerosolDrug
Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.
FOSTER®Drug
Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Beclometasone Dipropionate and Formoterol Inhalation Aerosol | Experimental | Each canister contains 120 actuations. Each actuation delivers 100 μg of beclomethasone dipropionate and 6 μg of formoterol fumarate. Receives: Drug: Beclometasone Dipropionate and Formoterol Inhalation Aerosol |
| FOSTER® | Active comparator | Each canister contains 120 actuations. Each actuation delivers 100 μg of beclomethasone dipropionate and 6 μg of formoterol fumarate. Receives: Drug: FOSTER® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced expiratory volume in 1 second (FEV1) at Week 4
Absolute change in FEV1 (in liters) from baseline to Week 4, measured by spirometry.
Measured: Baseline to Week 4.(at the end of the 4-week treatment period)
Secondary outcomes (11)
Change from baseline in mean daily diurnal variability of peak expiratory flow (PEF)
Change from baseline in mean daily diurnal variability rate of peak expiratory flow (PEF) at the end of the 2-week and 4-week treatment periods.(Unit: %; Time points: Baseline to Week 2; Baseline to Week 4.
Measured: Baseline to Week 2; Baseline to Week 4.
Change from baseline in trough (pre-dose) FEV1 at Week 2
Change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) at Week 2, measured at the end of the 2-week treatment period prior to the next inhalation.Unit: L; Time Frame: Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2).
Measured: Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2
Change from baseline in forced vital capacity (FVC) at Weeks 2 and 4 (end of treatment)
Liters (L)
Measured: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in FEV1/FVC ratio at Weeks 2 and 4 (end of treatment)
Percentage (%)
Measured: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in maximum mid-expiratory flow (MMEF), also known as forced expiratory flow between 25% and 75% of vital capacity (FEF25%-75%), at Weeks 2 and 4 (end of treatment)
Liters per second (L/s)
Measured: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in Asthma Control Questionnaire (ACQ-5) score at Weeks 2 and 4
Change from baseline in the Asthma Control Questionnaire (ACQ-5) score at Week 2 and Week 4. The ACQ-5 is a 5-item questionnaire with a total score ranging from 0 to 6 (mean of items), where higher scores indicate poorer asthma control.(Unit: Score on a 0-6 scale). Change from baseline in ACQ-5 score at Week 2 (Time Frame: Baseline to Week 2);Change from baseline in ACQ-5 score at Week 4 (Time Frame: Baseline to Week 4).
Measured: Baseline to Week 2; Baseline to Week 4.
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score at Weeks 2 and 4
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score at Week 2 and Week 4. The AQLQ is a 35-item questionnaire with a total score ranging from 1 to 5 (mean of all items), where higher scores indicate better quality of life.
Measured: Baseline to Week 2; Baseline to Week 4
Number of asthma exacerbations during the treatment period up to Weeks 2 and 4
An asthma exacerbation is defined as the occurrence of one or more of the following: (1) asthma-related serious adverse events (SAEs); (2) hospitalization or emergency department visit due to worsening of asthma; (3) need for a course of systemic corticosteroids (oral or injectable) for ≥3 days due to asthma worsening; (4) unscheduled visit leading to a change in therapy; or (5) withdrawal from the study due to lack of efficacy or requirement for a change in asthma medication. The cumulative number of exacerbations per patient will be recorded over the 2-week and 4-week treatment periods.Unit of Measure: Counts (number of events)
Measured: Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period)
Proportion of patients with at least one asthma exacerbation during the treatment period up to Weeks 2 and 4
Unit of Measure: Percentage (%). An asthma exacerbation is defined as the occurrence of one or more of the following: (1) asthma-related serious adverse events (SAEs); (2) hospitalization or emergency department visit due to worsening of asthma; (3) need for a course of systemic corticosteroids (oral or injectable) for ≥3 days due to asthma worsening; (4) unscheduled visit leading to a change in therapy; or (5) withdrawal from the study due to lack of efficacy or requirement for a change in asthma medication. The proportion of patients experiencing at least one exacerbation will be calculated over the 2-week and 4-week treatment periods.
Measured: Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period)
Rescue medication use during the treatment period
Measured: at Weeks 2 and 4
During the study period, monitor and record laboratory tests, ECGs, vital signs, and physical examinations; evaluate the type, incidence, severity, duration, and relationship to the investigational product of AEs and SAEs.
Measured: during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start8 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768891
- Sponsor's protocol ID
- BT-BF-IA-Ⅲ
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Phase III Clinical Study Comparing the Efficacy and Safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol Versus FOSTER® in Patients With Asthma.
- ClinicalTrials.gov ID
- NCT07768891
- Acronym / sponsor ID
- BT-BF-IA-Ⅲ
- Conditions
- Asthma (Diagnosis)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Aug 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.
A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclometasone Dipropionate and Formoterol Inhalation Aerosol | Experimental | Drug: Beclometasone Dipropionate and Formoterol Inhalation AerosolEach canister contains 120 actuations. Each actuation delivers 100 μg of beclomethasone dipropionate and 6 μg of formoterol fumarate. |
| FOSTER® | Active comparator | Drug: FOSTER®Each canister contains 120 actuations. Each actuation delivers 100 μg of beclomethasone dipropionate and 6 μg of formoterol fumarate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 and ≤75 years.
- Clinically diagnosed with bronchial asthma for at least 3 months at screening (with traceable diagnostic evidence and medical records), and the diagnosis has been confirmed according to the Guidelines for the Prevention and Management of Bronchial Asthma, meeting the following criteria:
- Within at least 4 weeks prior to signing the ICF, the subject has been on a stable daily dose of an inhaled corticosteroid (ICS) with "as-needed" short-acting β₂-agonist (SABA) use but asthma is not well controlled (ACQ-5 ≥1.00), OR has been on a stable daily dose of an ICS plus a long-acting β₂-agonist (LABA) and asthma is well controlled (ACQ-5 <1.00).
- Subjects who use SABA or other reliever medications as needed before screening may be enrolled only if the investigator assesses that they can be switched to the unified rescue medication provided in this study.
- Willing and able to comply with the protocol requirements and the investigator's instructions for pulmonary function tests, and, after training, able to correctly use the pressurized metered-dose inhaler (pMDI), peak flow meter, and complete the diary card records.
Key exclusion criteria (19 listed)
- Have intermittent asthma or asthma that occurs only upon occasional exposure to allergens or chemical sensitizers.
- Have a history of life-threatening asthma (e.g., brittle asthma, admission to the intensive care unit due to an acute asthma exacerbation) within 1 year prior to screening.
- Have other respiratory system diseases, including but not limited to allergic bronchopulmonary aspergillosis (ABPA), active tuberculosis, pneumonia, pneumothorax, idiopathic pulmonary fibrosis, clinically significant atelectasis, chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia, chronic bronchitis, or other significant pulmonary abnormalities other than asthma (such as cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency), and are considered by the investigator to be unsuitable for participation in this clinical study.
- Have a respiratory tract infection of non-viral etiology, sinusitis, or otitis media within 4 weeks prior to screening.
- Have a history of severe cardiovascular or cerebrovascular diseases, such as congestive heart failure of New York Heart Association (NYHA) class ≥II, unstable angina, coronary heart disease, myocardial infarction, stroke, etc., within 6 months prior to screening; have a prolonged QTc interval (QTc >450 ms for males or >470 ms for females, corrected using Fridericia's formula) or have ECG abnormalities that are assessed by the investigator as clinically significant and requiring pharmacological treatment; or have poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after adequate treatment).
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 |
|---|---|---|
| Beclometasone Dipropionate and Formoterol Inhalation AerosolBeclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks. | Drug | Beclometasone Dipropionate and Formoterol Inhalation Aerosol |
| FOSTER®Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks. | Drug | FOSTER® |
Primary outcome
Change from baseline in forced expiratory volume in 1 second (FEV1) at Week 4
Time frame: Baseline to Week 4.(at the end of the 4-week treatment period)
Absolute change in FEV1 (in liters) from baseline to Week 4, measured by spirometry.
11 secondary outcomes
Change from baseline in mean daily diurnal variability of peak expiratory flow (PEF)
Time frame: Baseline to Week 2; Baseline to Week 4.
Change from baseline in trough (pre-dose) FEV1 at Week 2
Time frame: Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2
Change from baseline in forced vital capacity (FVC) at Weeks 2 and 4 (end of treatment)
Time frame: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in FEV1/FVC ratio at Weeks 2 and 4 (end of treatment)
Time frame: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in maximum mid-expiratory flow (MMEF), also known as forced expiratory flow between 25% and 75% of vital capacity (FEF25%-75%), at Weeks 2 and 4 (end of treatment)
Time frame: Baseline to Week 2 and Week 4 (assessed at the end of each treatment period)
Change from baseline in Asthma Control Questionnaire (ACQ-5) score at Weeks 2 and 4
Time frame: Baseline to Week 2; Baseline to Week 4.
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score at Weeks 2 and 4
Time frame: Baseline to Week 2; Baseline to Week 4
Number of asthma exacerbations during the treatment period up to Weeks 2 and 4
Time frame: Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period)
Proportion of patients with at least one asthma exacerbation during the treatment period up to Weeks 2 and 4
Time frame: Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period)
Rescue medication use during the treatment period
Time frame: at Weeks 2 and 4
During the study period, monitor and record laboratory tests, ECGs, vital signs, and physical examinations; evaluate the type, incidence, severity, duration, and relationship to the investigational product of AEs and SAEs.
Time frame: during the study period
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 17 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Beclometasone Dipropionate and Formoterol Inhalation Aerosol and FOSTER® in people with Asthma (Diagnosis), run by Lunan Better Pharmaceutical Co., LTD. 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 7 inclusion and 19 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 17 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mei Ling Jin (021-31587861, MLjin118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in forced expiratory volume in 1 second (FEV1) at Week 4 (time frame: Baseline to Week 4.(at the end of the 4-week treatment period)). 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 17 Aug 2026.