Clinical trial NCT03726853: The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
Official title: A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Infection
Keywords: Acute upper respiratory infection
Acute bronchitis
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of CKD-497


Eligibility criteria: Inclusion Criteria:

1. 19 ≤ age \< 75
2. Subject with acute upper respiratory infection and acute bronchitis infection
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who need antibiotics treatment during the clinical trial
2. Subject suffering from severe respiratory diseases such as pneumonia, asthma, chronic closed lung diseases (COPD), tuberculosis, bronchial enlargement, malignant tumors in the lungs, and chronic bronchitis during screening
3. Subject who cannot participate in a clinical trial based on the PI's judgment

Primary outcomes:
measure: BSS(Bronchitis Severity Score)
timeFrame: 1 week
measure: SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Dong-gu
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
state: Dongjak-gu
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Gwangjin-gu
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyenggi-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Jongno-gu
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
state: Kangdong-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
state: Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Anam hospital
state: Seongbuk-gu
city: Seoul
country: Korea, Republic of
facility: EWHA Womans University Mokdong Hospital
state: Yangcheon-gu
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital
state: Yeongdeungpo-gu
Study officials:
References: