Evidence map›Paper›PMID 33569179›Full record

ArticleJournal of thoracic disease2021

The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial.

Seung Won Ra, Sun Young Kim, Yun Young Lim, Shin Jung Park, Chin Kook Rhee, Deog Kyeom Kim, Yong Bum Park, Chang Youl Lee, Hyoung Kyu Yoon, Jeong-Woong Park and 1 more

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of thoracic disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Seung Won RaDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Sun Young KimDepartment of Botanical Drug, Chong Kun Dang (CKD) Pharm Research Institute, Yongin-si, Gyeonggi-do, Korea.
Yun Young LimDepartment of Botanical Drug, Chong Kun Dang (CKD) Pharm Research Institute, Yongin-si, Gyeonggi-do, Korea.
Shin Jung ParkDepartment of Botanical Drug, Chong Kun Dang (CKD) Pharm Research Institute, Yongin-si, Gyeonggi-do, Korea.
Chin Kook RheeDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Deog Kyeom KimDepartment of Internal Medicine, Seoul National University Seoul Metropolitan Government Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
Yong Bum ParkDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea.
Chang Youl LeeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical Center, Chuncheon, Korea.
Hyoung Kyu YoonDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jeong-Woong ParkDivision of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
Kwang Ha YooDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Chong Kun Dang Bio (South Korea) · KRHallym University Medical Center · KRCatholic University of Korea · KRGachon University Gil Medical Center · KRKonkuk University · KRSeoul National University · KRThe Catholic University of Korea Yeouido St. Mary's Hospital · KRUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute upper respiratory tract infection (AURI) together with acute bronchitis is the most common illness worldwide. Botanical medicines used as expectorants and antitussives have proven to be effective while also having excellent safety margins. We aimed at evaluating the efficacy and safety of a new botanical drug, CKD-497, in patients with AURI and acute bronchitis.

methodsIn this phase 2 study, 225 patients were enrolled and randomly assigned to one of four treatment groups: placebo (n=55), Synatura

resultsBetween baseline and day 7, the mean BSS scores decreased significantly in each group (P<0.001): -4.04±1.85, -4.31±1.47, -4.09±1.48, and -4.28±1.69. However, neither the CKD-497 nor Synatura

conclusionsCKD-497 and even the positive control drug had no significant effect on BSS change in this phase 2 clinical trial. However, CKD-497 300 mg had a mild but significant clinical improvement in early bronchitis patients with more severe phlegm. Considering both efficacy and safety, a future study using 300 mg of CKD-497 with a shorter-term endpoint is warranted in patients with more severe bronchitis symptoms.

Indexed as

Acute respiratory tract infectionbronchitisbronchitis severity score (BSS)CKD-497

Identifiers

PMID33569179
PMCPMC7867795
OpenAlexW3122976677

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.