A Multi-center, Randomized, Double-blind, Active Control, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 12
- 主要终点
- Change From Baseline in Bronchitis Severity Score (BSS) Total Score at Day 7
研究概览
简要总结
This study compared two oral medicines containing Pelargonium sidoides extract in patients aged 12 to 75 years with acute bronchitis. Participants were randomly assigned to DSP2505 (Ckanium tablets) or Umckamin tablets for 7 days. The main question was whether DSP2505 was no worse than Umckamin by more than a defined margin in improving bronchitis symptoms. Symptoms, cough-related quality of life, overall improvement, satisfaction, and safety were assessed.
详细描述
This phase 4, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial was conducted at 12 hospitals in the Republic of Korea. Eligible patients had acute bronchitis with onset within 48 hours before randomization and a Bronchitis Severity Score (BSS) of at least 5 at screening and baseline. Following a screening period of up to 2 days, participants were randomized 1:1 to DSP2505 or Umckamin for 7 days. Randomization was stratified by baseline BSS (<8 or >=8). Matching placebos maintained blinding. Assessments were performed at baseline and the Day 7 end-of-treatment visit.
The primary endpoint was change in BSS total score from baseline to Day 7. The clinical study report describes an analysis of covariance with treatment as a fixed effect and baseline BSS as a covariate. Non-inferiority was assessed by comparing the upper bound of the two-sided 95% confidence interval for the adjusted difference (DSP2505 minus Umckamin) with a margin of 1.10 points. The per-protocol set was the primary efficacy analysis population, with a supporting full-analysis-set analysis. Safety was assessed in participants who received at least one dose.
This registration was prepared after study completion and analysis of the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators were blinded to treatment allocation. Each participant received one active tablet and one matching placebo tablet at each administration. Allocation codes were held in an interactive web response system and were intended to remain blinded until database lock, except for medically necessary emergency unblinding.
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 12 to 75 years, inclusive.
- •Acute bronchitis with onset within 48 hours before randomization and BSS total score >=5 at both screening and randomization.
- •Females of childbearing potential and males agree to medically acceptable contraception during the trial: ovulation-inhibiting combined hormonal contraception (oral, intravaginal, or transdermal); ovulation-inhibiting progestogen-only contraception (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/salpingectomy; bilateral oophorectomy; vasectomized partner; or sexual abstinence.
- •Negative pregnancy test before study medication in females of childbearing potential.
- •Voluntary written informed consent after explanation of the study. A legally authorized representative also provides written consent for participants younger than 19 years.
排除标准
- •Body temperature >38.5 degrees Celsius at randomization.
- •Respiratory disease that could affect efficacy assessment, including pneumonia, bronchial asthma, cystic fibrosis, viral influenza, active tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, or interstitial lung disease; or suspected pneumonia on chest radiography, auscultation, or vital signs.
- •Medical history or disease judged to affect the study, including a coagulation disorder, increased bleeding tendency, or abnormal coagulation test at screening; malignancy within 5 years (exceptions include completely excised basal/squamous cell carcinoma, radically resected papillary thyroid carcinoma, or successfully treated cervical carcinoma in situ at least 1 year previously; patients considered cured within the previous 5 years with no subsequent treatment or anticipated need for treatment may participate); or clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, or central nervous system disease or disorder.
- •History of psychiatric illness, alcoholism, or drug abuse.
- •Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Use or planned use of prohibited medication: anticoagulants at screening; systemic antibiotics/antivirals or systemic/inhaled glucocorticoids from 2 weeks before randomization through the final visit; ACE inhibitors from 1 week before randomization (4 weeks for perindopril) through the final visit, except stable dosing for an underlying condition; expectorants, mucolytics, antitussives, or herbal antitussive/expectorant products from 2 days before randomization through the final visit; or antihistamines, anticholinergics including bronchodilators, other symptomatic treatments for acute bronchitis, or analgesics throughout the study. Temporary acetaminophen for fever up to 1.5 g/day is permitted, except within 24 hours before Visits 2 and
- •ALT or AST >3 times the upper limit of normal, or estimated glomerular filtration rate <30 mL/min/1.73 m2 calculated using the CKD-EPI equation.
- •History of hypersensitivity to study medication ingredients.
- •Pregnancy or breastfeeding.
- •Average smoking of at least 15 cigarettes/day during the preceding 30 days.
- •Receipt of investigational medication or an investigational device in another trial within 30 days before screening, or current participation in another interventional trial.
- •Any other reason judged by the investigator to make participation inappropriate.
研究组 & 干预措施
Umckamin
Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days.
干预措施: Placebo Matching DSP2505 (Canium) (Drug)
DSP2505 (Canium)
DSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days.
干预措施: DSP2505(Canium) (Drug)
DSP2505 (Canium)
DSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days.
干预措施: Placebo Matching Umckamin (Drug)
Umckamin
Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days.
干预措施: Umckamin (Drug)
结局指标
主要结局
Change From Baseline in Bronchitis Severity Score (BSS) Total Score at Day 7
时间窗: Baseline and Day 7
BSS is the sum of five symptom scores: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each is rated from 0 (absent) to 4 (very severe), giving a total of 0 to 20. Higher scores indicate greater symptom severity. Change is Day 7 minus baseline; a negative change indicates improvement.
次要结局
- Change From Baseline in BSS Cough Score at Day 7(Baseline and Day 7)
- Change From Baseline in BSS Sputum Score at Day 7(Baseline and Day 7)
- Change From Baseline in BSS Rales/Rhonchi Score at Day 7(Baseline and Day 7)
- Change From Baseline in BSS Chest Pain During Coughing Score at Day 7(Baseline and Day 7)
- Change From Baseline in BSS Dyspnea Score at Day 7(Baseline and Day 7)
- Percentage of Participants With BSS Total Score Below 3 at Day 7(Baseline and Day 7)
- Percentage of Participants With a BSS Total Score Reduction of at Least 7 Points(Baseline and Day 7)
- Percentage of Participants Meeting Both BSS Response Criteria(Baseline and Day 7)
- Change From Baseline in Cough Assessment Test (COAT) Total Score at Day 7(Baseline and Day 7)
- Investigator-rated Global Improvement at Day 7(Day 7)
- Percentage of Participants With Investigator-rated Global Improvement at Day 7(Day 7)
- Percentage of Participants With Participant-rated Global Improvement at Day 7(Day 7)
- Participant Satisfaction With Treatment at Day 7(Day 7)
- Number of Participants With Treatment-emergent Adverse Events(From first dose through the Day 7 end-of-treatment assessment)
- Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests(Screening/before treatment and Day 7)
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Screening/before treatment and Day 7)
- Number of Participants With Clinically Significant Abnormalities in Physical Examination(Screening/before treatment and Day 7)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram(Screening/before treatment and Day 7)