A Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.

Dasan Pharmaceutical Co., Ltd.223 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

223

Conditions

Acute Bronchitis

Interventions

DSP2505(Canium)DRUG

Canium film-coated tablet containing 20 mg of Pelargonium sidoides 11% ethanol dry extract (5.5-6.6:1). One tablet orally three times daily for 7 days.

UmckaminDRUG

Tablet containing 111.111 mg of Pelargonium sidoides 11% ethanol extract (1:8-10) and maltodextrin mixture (1:4.56), equivalent to 20 mg of dried extract. One tablet orally three times daily for 7 days.

Placebo Matching UmckaminDRUG

One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients aged 12 to 75 years, inclusive. 2. Acute bronchitis with onset within 48 hours before randomization and BSS total score \>=5 at both screening and randomization. 3. 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. 4. Negative pregnancy test before study medication in females of childbearing potential. 5. Voluntary written informed consent after explanation of the study. A legally authorized representative also provides written consent for participants younger than 19 years. Exclusion Criteria: 1. Body temperature \>38.5 degrees Celsius at randomization. 2. 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. 3. 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. 4. History of psychiatric illness, alcoholism, or drug abuse. 5. Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 6. 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 3. 7. 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. 8. History of hypersensitivity to study medication ingredients. 9. Pregnancy or breastfeeding. 10. Average smoking of at least 15 cigarettes/day during the preceding 30 days. 11. Receipt of investigational medication or an investigational device in another trial within 30 days before screening, or current participation in another interventional trial. 12. Any other reason judged by the investigator to make participation inappropriate.

Locations (12)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Dong-A University Hospital

Busan, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Change From Baseline in Bronchitis Severity Score (BSS) Total Score at 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.