AsthmaPhase 2NCT06940700
Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma
A Phase 2 study testing SHR4597 and Budesonide inhalant in people with Asthma, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- SHR4597 and Budesonide inhalant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Dec 2025
- 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
- Age ≥18 years old and ≤75 years old, gender is not limited;
- Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
- Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
- Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
- FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and < 80% of the estimated value;
- Screening and baseline visit, Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5;
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- FeNO values at screening period and baseline ≥25 ppb;
- Patients with asthma who were treated for the first time or who had previously taken irregular medication were selected; Among them, the definition of irregular past use was: patients did not regularly use asthma control drugs within the first 3 months of enrollment, and the average weekly use compliance was < 50%.
- A fertile female subject or a male subject whose partner is a fertile female must agree not to have a family plan and to voluntarily use highly effective contraception (including the partner) from the time of signing the informed consent until 1 month after the last study drug administration, and refrain from sperm/egg donation;
- Voluntarily sign informed consent to participate in this study.
- The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
- The researchers determined that there were other circumstances that were not suitable for participation in this study.
Who cannot join
- Combined diseases or conditions
- Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);
- Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;
- A history of infection requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infection;
- ⑥ Known presence of parasitic infection within 6 months prior to randomization;
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- ⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;
- ⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and/or the need for invasive ventilator support [intubation/tracheotomy]);
- ⑨ History of acute asthma attack in the 4 weeks prior to randomization.
- Combination of medication or treatment
- Receiving non-selective beta-blockers (e.g., propranolol) within 1 week prior to screening;
- Live attenuated vaccine or recombinant vaccine with viral vector were received within 4 weeks before randomization;
- Receiving allergen immunotherapy 8 weeks before randomization;
- Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; For those with unknown half-lives, the first 12 weeks of randomization will be the use of systemic immunosuppressants (except for systemic glucocorticoids for asthma treatment, and systemic glucocorticoids for other conditions <3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, Including but not limited to methotrexate, cyclosporine, interferon-alpha, anti-IL-5 monoclonal antibody,anti-TSLP monoclonal antibody, anti-IGE monoclonal antibody, mesulast, etc.
- Receiving a single dose of long-acting β2 agonist within 4 weeks prior to screening; ⑥4 weeks before randomization, inhaled corticosteroids (>500 micrograms of beclomethasone dipropionate per day [BDP] or equivalent dose);
- ⑦4 weeks before randomization, systemic glucocorticoid therapy;
- Received bronchial thermoplasty or bronchial cryoablation within 1 year before randomization; ⑨There is a surgical plan during the study, or other treatment that the investigator believes may affect the evaluation of the subject;
- Laboratory examination
- ①Significant abnormalities during screening or baseline laboratory tests:
- White blood cell (WBC) < 3.0×109/L;
- Blood eosinophils >1500cells/μL (1.5×109/L)
- Hemoglobin (Hb) ≤90 g/L;
- Alanine aminotransferase (ALT) > 3×ULN (upper limit of normal);
- Aspartate aminotransferase (AST) > 3×ULN;
- Total bilirubin (TBIL) > 1.5×ULN;
- Prothrombin time (PT) > ULN+3s;
- Creatinine (Cr) > 1.5×ULN;
- Co-active hepatitis B (peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥1×103 IU[or copy] / mL), or hepatitis C antibody positive, or human immunodeficiency virus (HIV) positive, or treponema pallidum antibody positive.
- Prolonged ECG QTc interval (>450ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
- General situation
- Smoking or smoking cessation less than 6 months during the screening period, or previous smoking ≥10 pack years (pack years = number of years of smoking × number of packs per day); ②A history of drug use, alcohol abuse (average weekly consumption of ≥14 units of alcohol: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine) or drug abuse in the year prior to screening;
- Have participated in other clinical studies and used investigational drugs containing active ingredients within 30 days prior to screening, or have been within 5 half-lives of investigational drugs at the time of screening (whichever is older);
- Subjects who are pregnant (screening or baseline blood pregnancy test positive) or who plan to become pregnant while breastfeeding or during the study; ⑥Other reasons deemed unsuitable for study participation by the researcher.
- Excessive alcohol consumption and drug abuse were prohibited throughout the study period (the definition of excessive alcohol consumption is the same as exclusion criterion IV.2).
- Smoking (including e-cigarettes) was prohibited throughout the study period.
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
West China Hospital, Sichuan University
Chengdu, Sichuan
Fengming Luo
About this study
Official title: To Evaluate the Efficacy and Safety of SHR-4597 Inhalants in Adults With Asthma: a Multicenter, Randomized, Open-label, Positive-controlled Phase II Clinical Study
To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study
- Conditions
- Asthma
- Being tested
- SHR4597, Budesonide inhalant
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4597Drug
SHR4597
Budesonide inhalantDrug
Budesonide inhalant
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR4597 Receives: Drug: SHR4597 |
| Treatment group B | Experimental | SHR4597 Receives: Drug: SHR4597 |
| Treatment group C | Active comparator | Budesonide inhalant Receives: Drug: Budesonide inhalant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FEV1 (Pre-BD) from baseline
Measured: 6 weeks
Secondary outcomes (7)
Changes in FEV1 before bronchodilator (Pre-BD) administration compared with baseline at week 42
Measured: at week 42
Changes in forced vital capacity (FVC) before bronchodilator (Pre-BD) use compared with baseline at week 42
Measured: at week 42
Changes in peak expiratory flow (PEF) before bronchodilator (Pre-BD) use compared with baseline at week 42
Measured: at week 42
Changes in exhaled nitric oxide (FeNO) from baseline at 42 weeks
Measured: at 42 weeks
Changes in Asthma Control Questionnaire (ACQ-6) scores from baseline at 42 weeks
Measured: at 42 weeks
Change in mean number of nightly awakenings from baseline over 42 weeks
Measured: 42 weeks
Changes in ACT questionnaire scores from baseline at 42 weeks
Measured: at 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940700
- Sponsor's protocol ID
- SHR-4597-201
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of SHR-4597 Inhalants in Adults With Asthma: a Multicenter, Randomized, Open-label, Positive-controlled Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06940700
- Acronym / sponsor ID
- SHR-4597-201
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Apr 2025 (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.
To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR4597SHR4597 |
| Treatment group B | Experimental | Drug: SHR4597SHR4597 |
| Treatment group C | Active comparator | Drug: Budesonide inhalantBudesonide inhalant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and ≤75 years old, gender is not limited;
- Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
- Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
- Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
- FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and < 80% of the estimated value;
Key exclusion criteria (35 listed)
- Combined diseases or conditions
- ⑥ Known presence of parasitic infection within 6 months prior to randomization;
- ⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;
- ⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and/or the need for invasive ventilator support [intubation/tracheotomy]);
- ⑨ History of acute asthma attack in the 4 weeks prior to randomization.
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 |
|---|---|---|
| SHR4597SHR4597 | Drug | Treatment group A, Treatment group B |
| Budesonide inhalantBudesonide inhalant | Drug | Treatment group C |
Primary outcome
Changes in FEV1 (Pre-BD) from baseline
Time frame: 6 weeks
7 secondary outcomes
Changes in FEV1 before bronchodilator (Pre-BD) administration compared with baseline at week 42
Time frame: at week 42
Changes in forced vital capacity (FVC) before bronchodilator (Pre-BD) use compared with baseline at week 42
Time frame: at week 42
Changes in peak expiratory flow (PEF) before bronchodilator (Pre-BD) use compared with baseline at week 42
Time frame: at week 42
Changes in exhaled nitric oxide (FeNO) from baseline at 42 weeks
Time frame: at 42 weeks
Changes in Asthma Control Questionnaire (ACQ-6) scores from baseline at 42 weeks
Time frame: at 42 weeks
Change in mean number of nightly awakenings from baseline over 42 weeks
Time frame: 42 weeks
Changes in ACT questionnaire scores from baseline at 42 weeks
Time frame: at 42 weeks
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 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 2 study testing SHR4597 and Budesonide inhalant in people with Asthma, run by Guangdong Hengrui 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 12 inclusion and 35 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: opening soon, as of the sponsor's last update on 23 Apr 2025. 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 Zi Lin (+0518-81220121, zi.lin.zl30@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FEV1 (Pre-BD) from baseline (time frame: 6 weeks). 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 23 Apr 2025.