The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients

Last updated: May 10, 2024
Sponsor: SamA Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

4

Condition

Bronchitis

Bronchitis (Pediatric)

Treatment

Placebo

Atock Dry Syrup

Clinical Study ID

NCT06411925
SA21901-2
  • Ages 6-11
  • All Genders

Study Summary

Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children aged ≥6 months to <12 years old

  2. Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4

  3. Wheezing score ≥2

  4. Subjects who present symptoms of Acute Bronchitis within 48 hours from screeningvisit

Exclusion

Exclusion Criteria:

  1. Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severerespiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, activetuberculosis)

  2. Subjects under treatment with corticosteroids, antibiotics medications

  3. Subjects with severe hepatic and renal impairment

  4. Subjects with a history of drug abuse

  5. Subject with positive results in HbsAg or HCV Ab or HIV Ab tests at screening visit

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 10, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Soonchunhyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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