- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002192
A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University Peoples Hospital
-
Contact:
- Bingbing Wu, Associate Chief Physician
- Phone Number: 13661179832
- Email: dr_bingbingl@sina.com
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Weihua Lai, Chief Pharmacist
- Phone Number: 13570042336
- Email: laiweihuax@163.com
-
Guangzhou, Guangdong, China, 510120
- Withdrawn
- The First Affiliated Hospital of Guangzhou Medical University
-
Shenzhen, Guangdong, China, 518037
- Recruiting
- Shenzhen Second People's Hospital
-
Contact:
- Jianlong Wu, Chief Pharmacist
- Phone Number: 13802555718
- Email: wjl06@163.com
-
-
Hubei
-
Wuhan, Hubei, China, 430071
- Recruiting
- Zhongnan Hospital of Wuhan University
-
Contact:
- Yan Zhao, Chief Physician
- Phone Number: 13995577963
- Email: 941615059@qq.com
-
Contact:
- Xianlong Zhou, Physician-in-charge
- Phone Number: 18627839314
- Email: xianlongzhou@whu.edu.cn
-
Principal Investigator:
- Yan Zhao, Chief Physician
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
-
Contact:
- Jinfu Xu, Chief Physician
- Phone Number: 13321922898
- Email: jfxucn@163.com
-
Contact:
- Haiwen Lu, Associate Chief Physician
- Phone Number: 13917110982
- Email: haiwen_lu@163.com
-
Principal Investigator:
- Jinfu Xu, Chief Physician
-
Shanghai, Shanghai, China, 200020
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Contact:
- Jieming Qu, Chief Physician
- Phone Number: 18901661180
- Email: puffymoonlight@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This study adopts a retrospective research design to analyze the real-world data of Eucalyptol, Limonene and Pinene Enteric Soft Capsules, to evaluate the effectiveness, safety and economy of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the real clinical treatment of community-acquired pneumonia patients.
It is estimated that approximately 10,000 subjects from the six hospitals will meet the enrollment criteria to enter this retrospective real-world study.
Description
Inclusion Criteria:
- Patients with community-acquired pneumonia
- Inpatients from 2017 to 2019
- Regardless of age and gender
Exclusion Criteria:
- Patients diagnosed with hospital-acquired pneumonia
- Patients who take two or more oral mucolytics
- Patients with combined use of Chinese and Western expectorants other than mucolytic drugs
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ELP_ONLY
Patients who were diagnosed with community-acquired pneumonia and were treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules, not treated with other oral mucolytics.
|
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
|
EXP_ONLY
Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
|
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
|
ELP+AMB
Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
|
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and cohort EXP+AMB Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort
|
EXP+AMB
Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
|
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and cohort EXP+AMB Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort
|
AMB_ONLY
Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.
|
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and cohort EXP+AMB Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of cough-related symptoms improvement
Time Frame: 7 days
|
Rate of cough-related symptoms improvement in the expectorant treatment of inpatients with community-acquired pneumonia. Compared the differences of the rates of cough improvement between the experiment group and the control group. The cough-related symptoms are evaluated and recorded in the inpatients' medical records. All the descriptions of cough-related symptoms and assessments in every inpatient's medical records will be captured. |
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of overal cure and improvement in pneumonia treatment
Time Frame: Up to 30 days
|
The overal pneumonia treatment results, include cured, improved, dead and other states, are assessed and recorded in the discharge summaries.
The overal cure and improvement rate calculation in every group is based on the cured and improved states.
|
Up to 30 days
|
Hospitalization length of stay
Time Frame: Up to 30 days
|
The mean hospitalization length of stay in every group is analyzed according the discharge summaries.
|
Up to 30 days
|
Rate of pulmonary imageological improvement
Time Frame: Up to 30 days
|
The pulmonary imageological resultes include improved, deteriorative and unchanged states.
The improvement rate calculation in every group is based on the improved state according to the last imageological reports before discharge.
|
Up to 30 days
|
Rate of normalization of vital signs
Time Frame: 7 days
|
The vital signs, include temperature, pulse and respirations, are measured during the pre and post treatment.
The normalization rate of vital signs is analyzed among the patients with abnormal vital signs measurements before treatment.
|
7 days
|
Rate of normalization of inflammatory index of pneumonia
Time Frame: 7 days
|
The Inflammatory indexes of pneumonia, include CRP, PCT, SAA, WBC, IL-6 and lymphocyte count, are measured during the pre and post treatment.
The normalization rates of inflammatory indexes of pneumonia are analyzed among the patients with abnormal indexes measurements before treatment
|
7 days
|
Safety assessment: adverse events
Time Frame: Up to 30 days after first dose
|
Assess safety through monitoring of adverse events, and the collection of conventional laboratory data.
All the adverse events during the pre and post treatment will be captured.
|
Up to 30 days after first dose
|
Cost-effectiveness ratio
Time Frame: Up to 30 days
|
The all-cause healthcare will be determined by all the costs happened during the whole hospital stays (i.e.,skilled nursing facility, total medical, prescriptions).
Effectiveness will be measured by the primary outcome, the rate of cough-related symptoms improvement within 7 days.
The cost-effectiveness ratio is determined by the ratio of the all-cause healthcare to the rate of cough-related symptoms improvement within 7 days.
|
Up to 30 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.
- Koo HJ, Lim S, Choe J, Choi SH, Sung H, Do KH. Radiographic and CT Features of Viral Pneumonia. Radiographics. 2018 May-Jun;38(3):719-739. doi: 10.1148/rg.2018170048.
- Wang C, Shi QP, Ding F, Jiang XD, Tang W, Yu ML, Cheng JQ. Reevaluation of the post-marketing safety of Xuebijing injection based on real-world and evidence-based evaluations. Biomed Pharmacother. 2019 Jan;109:1523-1531. doi: 10.1016/j.biopha.2018.10.190. Epub 2018 Nov 14.
- Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.
- Agbabiaka TB, Savovic J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008;31(1):21-37. doi: 10.2165/00002018-200831010-00003.
- Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.
- van Rensburg DJ, Perng RP, Mitha IH, Bester AJ, Kasumba J, Wu RG, Ho ML, Chang LW, Chung DT, Chang YT, King CH, Hsu MC. Efficacy and safety of nemonoxacin versus levofloxacin for community-acquired pneumonia. Antimicrob Agents Chemother. 2010 Oct;54(10):4098-106. doi: 10.1128/AAC.00295-10. Epub 2010 Jul 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YD_SMQD_ELP_202009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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