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

NCT07835620 | Completed Phase 4 DMC

• 1 other identifier: DSP2505-CT4
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Acute Bronchitis

Keywords

Pelargonium sidoides; Non-inferiority; Herbal medicine; DSP2505; BSS; COAT; Ckanium; Umckamin

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 7

Secondary Outcomes (18)

• 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

Study Arms (2)

DSP2505 (Canium)

EXPERIMENTAL

DSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days.

Drug: DSP2505(Canium); Drug: Placebo Matching Umckamin

Umckamin

ACTIVE COMPARATOR

Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days.

Drug: Umckamin; Drug: Placebo Matching DSP2505 (Canium)

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.

DSP2505 (Canium)

Umckamin DRUG

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.

Umckamin

Placebo Matching Umckamin DRUG

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

DSP2505 (Canium)

Placebo Matching DSP2505 (Canium) DRUG

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

Umckamin

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 3.
• 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.

Sponsors & Collaborators

• Dasan Pharmaceutical Co., Ltd.: lead
• Konkuk University Hospital: collaborator
• Dong-A University Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Wonkwang University Hospital: collaborator
• InjeUniversityBusanPaikHospital: collaborator
• Hallym University Kangnam Sacred Heart Hospital: collaborator
• Hallym University Medical Center: collaborator
• Ulsan University Hospital: collaborator
• Yeouido St. Mary's Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Eunpyeong St. Mary's Hospital: collaborator

Study Sites (12)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Dong-A University Hospital

Busan, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Incheon St. Mary's Hospital, The Catholic University of Korea

Incheon, South Korea

Location

Eunpyeong St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Yeouido St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Kwang Ha Yoo

  Konkuk University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parallel groups, assigned 1:1, with randomization stratified by baseline BSS (\<8 or \>=8). Double-dummy active-controlled non-inferiority comparison.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 23, 2026
• Study Start: January 26, 2026
• Primary Completion: April 21, 2026
• Study Completion: September 9, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

KR (12)