Actively Recruiting
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
Led by Reistone Biopharma Company Limited · Updated on 2026-06-05
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of RSS0343 tablets in patients with chronic obstructive pulmonary disease (COPD). This Phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial focuses on patients aged 40 to 80 years diagnosed with COPD, aiming to measure the annual rate of moderate or severe COPD exacerbations over a 48-week treatment period. The study consists of three periods: a 4-week screening phase, a 48-week treatment phase where participants receive either RSS0343 tablets or a placebo, and a 4-week follow-up phase. Participants continue their usual COPD maintenance therapies and receive the study drug or placebo under close monitoring throughout the treatment period. Participants will undergo regular assessments including lung function tests such as forced expiratory volume (FEV1) and forced vital capacity (FVC), symptom evaluations with COPD Assessment Test (CAT), Evaluating Respiratory Symptoms in COPD (E-RS:COPD), and quality of life measures like the St. George's Respiratory Questionnaire (SGRQ). Researchers will track exacerbation rates, symptom changes, and safety throughout the study, with a total participation time of approximately 56 weeks.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Aged 40 to 80 years, male or female.
- Body mass index (BMI) of 18 kg/m² or higher.
- Diagnosed with COPD according to the Chinese Guidelines, with at least 12 months of history before screening.
- Post-bronchodilator FEV1/FVC ratio less than 0.7 at screening and baseline, with FEV1% predicted 20% or higher.
- History of at least one moderate or severe COPD exacerbation within 12 months before screening.
- On stable dual or triple COPD maintenance therapy for at least 3 months before screening.
- COPD Assessment Test (CAT) score of 10 or higher at screening and randomization.
- Current or former smoker with at least 10 pack-years history.
- Women and men of childbearing potential must use effective contraception as specified and women must have a negative pregnancy test and not be lactating.
You will not qualify if you...
- Use of systemic immunosuppressants, biologics, or Th2 cytokine inhibitors within 12 weeks before randomization.
- Use of medications that may cause skin hyperkeratosis within 4 weeks before screening.
- Use of systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussives/expectorants, or blood products within 4 weeks before randomization.
- Use of strong CYP3A inducers or inhibitors within 14 days or 5 half-lives before randomization.
- Vaccination with live or viral vector vaccines within 4 weeks before randomization.
- Participation in another clinical trial with investigational products within 3 months before screening or still within 5 half-lives.
- Prior treatment with RSS0343 or similar mechanism products within 3 months before screening.
- Lung surgery or bronchitis interventions within 1 year before screening.
- Need for supplemental oxygen more than 15 hours per day or mechanical ventilation; significant sleep apnea requiring CPAP or NIPPV.
- Moderate or severe COPD exacerbation within 4 weeks before screening.
- Other respiratory diseases or infections requiring systemic treatment within 4 weeks before randomization.
- Autoimmune diseases involving eosinophils.
- Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
- Presence of psoriasis, lichen planus, reactive arthritis, lupus, atopic or chronic dermatitis, chloracne, verruca vulgaris, or keratotic dermatitis.
- Severe other medical conditions.
- Abnormal lab tests, ECG, or other exams as per protocol.
- Known hypersensitivity to the study drug or its components.
- Recent blood donation or transfusion as specified.
- Lactating women, positive pregnancy test, or plans to become pregnant during the study.
- History of drug or substance abuse within 1 year before screening.
- Other medical or social reasons making participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive RSS0343 tablets or placebo to evaluate efficacy and safety in managing COPD symptoms.
Visits at weeks 4, 8, 12, 24, 36, and 48 for assessments
Duration - 4 weeks
Participants are monitored after treatment to assess long-term effects and safety.
1 visit at week 52
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
Actively Recruiting
Research Team
Z
Zhou Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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