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Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

ConditionAcute Bronchitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAhn-Gook Pharmaceuticals Co.,Ltd

About this trial

This is a Phase 3, randomized, double-blind, active-controlled clinical trial designed to evaluate the efficacy and safety of AG2001 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥19 years to <65 years old

Subjects who present symptoms of Acute Bronchitis with cough and sputum symptoms within 48 hours prior the randomization visit(Visit 2) who satisfy the following

Total Bronchitis Severity Scale ≥ 5

Total Bronchitis Severity Scale sputum score ≥ 2

Disqualifiers

Chronic respiratory diseases (e.g., COPD, asthma, pneumonia, tuberculosis, lung cancer)

Clinically significant hepatic, renal, cardiovascular, or neurological disorders

Use of prohibited medications (e.g., antibiotics, antivirals, corticosteroids) within the washout period

Positive test for hepatitis B, hepatitis C, or HIV

Trial design

Design model

Parallel

Treatments tested in this trial

  • AG2001

    Drug

    Oral administration, three times daily for 7 days.

  • AG20011

    Drug

    Oral administration, three times daily for 7 days.

  • AG20012

    Drug

    Oral administration, three times daily for 7 days.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: AG2001Experimental treatment 1 intervention
Group B: AG20011Active comparator 1 intervention
Group C: AG20012Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Bronchitis Severity Score (BSS) from Baseline to Day 4

The difference in BSS total score compared between treatment and comparator groups.

Time frame
Baseline to Day 4

Secondary outcomes

1

Change in Bronchitis Severity Score (BSS) from Baseline to Day 7

Evaluation of the change in BSS total score between baseline and Day 7.

Time frame
Baseline to Day 7
2

Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7

Assessment of individual BSS subscale scores including cough and sputum severity.

Time frame
Baseline to Day 4 and Day 7
3

Proportion of BSS Responders at Day 4 and Day 7

Percentage of participants achieving predefined responder criteria based on BSS score improvement.

Time frame
Baseline to Day 4 and Day 7
4

Change in Integrative Medicine Outcome Scale (IMOS)

Evaluation of IMOS scores as secondary endpoints.

Time frame
Baseline to Day 4 and Day 7

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahn-Gook Pharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: