Acute Upper Respiratory Tract Infections, Bronchitis
Conditions
Keywords
acute upper respiratory tract infection, chronic inflamatory bronchitis
Brief summary
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.
Interventions
DRUGAG NPP709syrup
Sponsors
Kyunghee University Medical Center
Inha University Hospital
Ewha Womans University
Hanyang University
Konkuk University Medical Center
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Months to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent 2. Patient ages between 24months and 75years 3. Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing 4. Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection
Exclusion criteria
1. Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis 2. Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders 3. Patient whose fructose intolerance 4. Patient who has hypersensitivity anamnesis of Prospan syrup 5. Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant 6. Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease 7. Patient who has uncontrolled diabetes or uncontrolled hypertensions 8. Patient who has experience to have participated in other clinical trial within two months before starting the trial 9. Pregnant women, lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement by global assessment | 5 days | At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as clinical success. |
Secondary
| Measure | Time frame |
|---|---|
| determine safety by unwanted reaction, clinical laboratory test and physical examination | 5 days |
Countries
South Korea
Outcome results
None listed