The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
ConditionAcute Bronchitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-11
SponsorSamA Pharmaceutical Co., Ltd
About this trial
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged ≥6 months to <12 years old
Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
Wheezing score ≥2
Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit
Disqualifiers
Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
Subjects under treatment with corticosteroids, antibiotics medications
Subjects with severe hepatic and renal impairment
Subjects with a history of drug abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Atock Dry Syrup with placebo patch
DrugAtock Dry syrup (TID) with placebo patch (QD)
Tulobuterol patch with placebo dry syrup
DrugTulobuterol patch (QD) with placebo dry syrup (TID)
Treatment groups
296 Participants
are divided into 2 treatment groupsGroup A: Atock Dry SyrupExperimental treatment 1 intervention
Group B: tulobuterol patchActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The rate of subjects whose symptoms improved based on the wheezing score at 3 days
The rating was: 0=No wheezing (None); 1=mild (End expiration with stethoscope); 2=moderate (Inspiration and expiration with stethoscope) and 3=severe (Audible without stethoscope).
Time frame
3 days treatment periodSecondary outcomes
1
The rate of subjects whose symptoms improved based on the wheezing score at 7 days
Time frame
7 days treatment period2
The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days
Time frame
3 and 7 days treatment period3
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days
• The BSSEs comprises the following four symptoms typical for Acute Bronchitis: cough, chest pain on coughing, crackle and dyspnea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
Time frame
3 and 7 days treatment period4
The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days
VAS consists of a horizontal line, usually 100 in length and select a point on the scale indicating the level of satisfaction for wheezing in the 3 and 7 days. The number 0 indicates not satisfaction and 100 indicates very satisfaction.
Time frame
3 and 7 days treatment periodSponsors and contacts
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Source ClinicalTrials.gov