Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis

Yuhan

Status and phase: Enrolling; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: YHR2403; Drug: YHR2402; Drug: YHP2401

Study type: Interventional

Funder types: Industry

Identifiers

NCT07111468

YHP2401-301

Details and patient eligibility

About

A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis

Enrollment: 279 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants 19 years ≤ age ≤ 80 years
• Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)
• BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1
• Patients who voluntarily signed the consent form

Exclusion criteria

• Severe lung disease as determined by the investigator
• Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis
• Active infection requiring systemic antibiotic treatment
• Patients who need to take contraindicated concomitant medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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279 participants in 3 patient groups

YHP2401

Experimental group

Treatment:

Drug: YHP2401

YHR2402

Active Comparator group

Treatment:

Drug: YHR2402

YHR2403

Active Comparator group

Treatment:

Drug: YHR2403