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Completed

NCT Number: NCT05344638

A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Konkuk University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender, 19 years ≤ age ≤ 75 years
  • BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
  • Patients without fever based on Visit 2(Randomized Visit)
  • Those who can comply with the requirements of clinical trials
  • Written consent voluntarily to participate in this clinical trial

Exclusion criteria

  • Patients with respiratory and systemic infections requiring systemic antibiotic therapy
  • Patients with bleeding tendency or coagulation disorder
  • Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  • Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
  • In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons

Treatment and study plan

AGS (Experimental)

Drug

tid

AGU (Active Comparator)

Drug

tid

Primary outcomes

  1. Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2

    Time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

    The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe

Secondary outcomes

  1. Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2

    Time frame: 7days

  2. Treatment response rate at Visit 3

    Time frame: 7days

  3. Integrative Medicine Outcome Scale (IMOS)

    Time frame: 7days

  4. Integrative Medicine Patient Satisfaction Scale (IMPSS)

    Time frame: 7days

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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