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

Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05344638
Collaborator
(none)
220
1
2
9.4
23.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: AGS (Experimental)
  • Drug: AGU (Active Comparator)
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 17, 2019
Actual Primary Completion Date :
Jul 29, 2020
Actual Study Completion Date :
Jul 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: AGS (Experimental)

AGS + Placebo of AGU

Drug: AGS (Experimental)
tid

Active Comparator: AGU (Active Comparator)

Placebo of AGS + AGU

Drug: AGU (Active Comparator)
tid

Outcome Measures

Primary Outcome Measures

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

  1. Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2 [7days]

  2. Treatment response rate at Visit 3 [7days]

  3. Integrative Medicine Outcome Scale (IMOS) [7days]

  4. Integrative Medicine Patient Satisfaction Scale (IMPSS) [7days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konkuk University Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Ahn-Gook Pharmaceuticals Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05344638
Other Study ID Numbers:
  • AG1904
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022