Chronic Obstructive Pulmonary DiseasePhase 2NCT07349524
A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing RSS0343 tablets in people with Chronic Obstructive Pulmonary Disease, run by Reistone Biopharma Company Limited at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- RSS0343 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to Apr 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign a written informed consent form.
- Aged 40 to 80 years, male or female.
- Body mass index (BMI) ≥18 kg/m².
- Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.
- Post-bronchodilator FEV₁/FVC <0.7 at the screening period; and post-bronchodilator FEV₁/FVC <0.7 with FEV₁% predicted ≥20% at baseline.
- Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.
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- On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.
- COPD Assessment Test (CAT) score ≥10 at screening and randomization.
- Current or former smoking history of ≥10 pack-years at screening.
- Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm/ova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.
Who cannot join
- Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.
- Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
- Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, infusion of blood products or immunoglobulins.
- Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
- Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.
- Participation in another clinical trial involving an investigational product with active ingredients within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening.
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- Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.
- Lung surgery or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.
- Requirement for supplemental oxygen therapy for ≥15 hours per day or mechanical ventilation; or clinically significant sleep apnea requiring the use of a continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
- Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.
- Coexisting other respiratory or respiratory-related diseases.
- Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.
- Presence of autoimmune diseases mediated by eosinophils at screening.
- Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
- Diagnosis of psoriasis or lichen planus; Reiter's disease/keratoderma blennorrhagicum, keratoderma hemorrhagicum, or reactive arthritis; systemic lupus erythematosus, atopic dermatitis, chronic hand dermatitis, chronic contact dermatitis, or chronic psoriasis; chloracne, extensive verruca vulgaris, or keratotic dermatitis.
- Known other severe medical conditions.
- Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria.
- Suspected or known hypersensitivity to the investigational product or any of its excipients.
- Blood donation or blood loss ≥200 mL within 1 month prior to randomization, or ≥400 mL within 3 months prior to the first dose; or receipt of a blood transfusion within 8 weeks prior to the first dose; or difficulty with venipuncture, or physical condition unsuitable for intensive blood sampling.
- Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period.
- History of drug abuse or substance abuse within 1 year prior to screening.
- Any other medical or social reason deemed 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
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510140
Weijie Guan
About this study
Official title: Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- RSS0343 tablets, RSS0343 tablets Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0343 tabletsDrug
RSS0343 tablets
RSS0343 tablets PlaceboDrug
RSS0343 tablets Placebo
| Study group | Role | What they receive |
|---|---|---|
| RSS0343 tablets | Experimental | Not described Receives: Drug: RSS0343 tablets |
| RSS0343 tablets Placebo | Placebo comparator | Not described Receives: Drug: RSS0343 tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
Measured: during the 48-week treatment period
Secondary outcomes (10)
The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36；
Measured: at week 12, 24, and 36;
The time to first moderate or severe exacerbations of COPD at week 24 and 48;
Measured: at week 24 and 48;
The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48
Measured: at week 24 and 48
The change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁) at week 4, 8, 12, 24, 36, 48, and 52
Measured: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in FEV₁% predicted at week 4, 8, 12, 24, 36, 48, and 52
Measured: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in forced vital capacity (FVC) at week 4, 8, 12, 24, 36, 48, and 52;
Measured: at week 4, 8, 12, 24, 36, 48, and 52;
The change from baseline in the COPD Assessment Test (CAT) score at week 4, 8, 12, 24, 36, 48, and 52
Measured: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score at week 4, 8, 12, 24, 36, 48, and 52
Measured: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the St. George's Respiratory Questionnaire (SGRQ) score at week 4, 8, 12, 24, 36, 48, and 52;
Measured: at week 4, 8, 12, 24, 36, 48, and 52;
The proportion of patients with a SGRQ response (a ≥4-point decrease from baseline) at week 48;
Measured: at week 48;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start10 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349524
- Sponsor's protocol ID
- RSS0343-202
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT07349524
- Acronym / sponsor ID
- RSS0343-202
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 16 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.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSS0343 tablets | Experimental | Drug: RSS0343 tablets |
| RSS0343 tablets Placebo | Placebo comparator | Drug: RSS0343 tablets Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily sign a written informed consent form.
- Aged 40 to 80 years, male or female.
- Body mass index (BMI) ≥18 kg/m².
- Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.
- Post-bronchodilator FEV₁/FVC <0.7 at the screening period; and post-bronchodilator FEV₁/FVC <0.7 with FEV₁% predicted ≥20% at baseline.
Key exclusion criteria (22 listed)
- Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.
- Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
- Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, infusion of blood products or immunoglobulins.
- Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
- Administration of live, attenuated live, or viral vector vaccines within 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 |
|---|---|---|
| RSS0343 tabletsRSS0343 tablets | Drug | RSS0343 tablets |
| RSS0343 tablets PlaceboRSS0343 tablets Placebo | Drug | RSS0343 tablets Placebo |
Primary outcome
Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
Time frame: during the 48-week treatment period
10 secondary outcomes
The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36；
Time frame: at week 12, 24, and 36;
The time to first moderate or severe exacerbations of COPD at week 24 and 48;
Time frame: at week 24 and 48;
The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48
Time frame: at week 24 and 48
The change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁) at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in FEV₁% predicted at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in forced vital capacity (FVC) at week 4, 8, 12, 24, 36, 48, and 52;
Time frame: at week 4, 8, 12, 24, 36, 48, and 52;
The change from baseline in the COPD Assessment Test (CAT) score at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the St. George's Respiratory Questionnaire (SGRQ) score at week 4, 8, 12, 24, 36, 48, and 52;
Time frame: at week 4, 8, 12, 24, 36, 48, and 52;
The proportion of patients with a SGRQ response (a ≥4-point decrease from baseline) at week 48;
Time frame: at week 48;
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 5 Jun 2026.
- 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 RSS0343 tablets in people with Chronic Obstructive Pulmonary Disease, run by Reistone Biopharma Company Limited 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 10 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 5 Jun 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. Some participants in this study may receive a placebo. 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 Zhou Li (+86 17721288193, zhou.li.zl69@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period (time frame: during the 48-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 5 Jun 2026.