Community-acquired PneumoniaNCT05002192
A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
An observational study of Community-acquired Pneumonia, run by Beijing Grand Johamu Pharmaceutical Company, Ltd. at 7 sites in China.
Trial summary
Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Eucalyptol, Limonene and Pinene Enteric Soft Capsule, Ambroxol injection and Other oral mucolytic drugs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10,000 participants
- Where
- 7 sitesChina
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with community-acquired pneumonia
- Inpatients from 2017 to 2019
- Regardless of age and gender
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 6 recruiting
- Recruiting
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Bingbing Wu, Associate Chief Physician, 13661179832, dr_bingbingl@sina.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Weihua Lai, Chief Pharmacist, 13570042336, laiweihuax@163.com
- Withdrawn
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Jieming Qu, Chief Physician, 18901661180, puffymoonlight@126.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Jinfu Xu, Chief Physician, 13321922898, jfxucn@163.com
Haiwen Lu, Associate Chief Physician, 13917110982, haiwen_lu@163.com
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518037
Jianlong Wu, Chief Pharmacist, 13802555718, wjl06@163.com
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yan Zhao, Chief Physician, 13995577963, 941615059@qq.com
Xianlong Zhou, Physician-in-charge, 18627839314, xianlongzhou@whu.edu.cn
About this study
Official title: A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Eucalyptol, Limonene and Pinene Enteric Soft Capsule, Ambroxol injection, Other oral mucolytic drugs
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eucalyptol, Limonene and Pinene Enteric Soft CapsuleDrug
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
Ambroxol injectionDrug
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
Other oral mucolytic drugsDrug
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule | |
| EXP_ONLY | Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules. Receives: Drug: Other oral mucolytic drugs | |
| ELP+AMB | Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection. Receives: Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule; Drug: Ambroxol injection | |
| 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. Receives: Drug: Ambroxol injection; Drug: Other oral mucolytic drugs | |
| AMB_ONLY | Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone. Receives: Drug: Ambroxol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cough-related symptoms improvement
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.
Measured: 7 days
Secondary outcomes (7)
Rate of overal cure and improvement in pneumonia treatment
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.
Measured: Up to 30 days
Hospitalization length of stay
The mean hospitalization length of stay in every group is analyzed according the discharge summaries.
Measured: Up to 30 days
Rate of pulmonary imageological improvement
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.
Measured: Up to 30 days
Rate of normalization of vital signs
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.
Measured: 7 days
Rate of normalization of inflammatory index of pneumonia
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
Measured: 7 days
Safety assessment: adverse events
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.
Measured: Up to 30 days after first dose
Cost-effectiveness ratio
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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Grand Johamu Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002192
- Sponsor's protocol ID
- YD_SMQD_ELP_202009
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29757717Pan 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.
PubMed 32053470Wang 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.
PubMed 30551404Naranjo 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.
PubMed 7249508Agbabiaka 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.
PubMed 18095744Fine 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.
PubMed 8995086van 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.
PubMed 20660689
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05002192
- Acronym / sponsor ID
- YD_SMQD_ELP_202009
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Grand Johamu Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ELP_ONLY | – | Drug: Eucalyptol, Limonene and Pinene Enteric Soft CapsulePatients who were diagnosed with community-acquired pneumonia and were treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules, not treated with other oral mucolytics. |
| EXP_ONLY | – | Drug: Other oral mucolytic drugsPatients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules. |
| ELP+AMB | – | Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule, Drug: Ambroxol injectionPatients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection. |
| EXP+AMB | – | Drug: Ambroxol injection, Drug: Other oral mucolytic drugsPatients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules. |
| AMB_ONLY | – | Drug: Ambroxol injectionPatients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with community-acquired pneumonia
- Inpatients from 2017 to 2019
- Regardless of age and gender
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eucalyptol, Limonene and Pinene Enteric Soft CapsuleCompare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort | Drug | ELP+AMB, ELP_ONLY |
| Ambroxol injectionCompare 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 | Drug | AMB_ONLY, ELP+AMB, EXP+AMB |
| Other oral mucolytic drugsCompare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort | Drug | EXP+AMB, EXP_ONLY |
Primary outcome
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 secondary outcomes
Rate of overal cure and improvement in pneumonia treatment
Time frame: Up to 30 days
Hospitalization length of stay
Time frame: Up to 30 days
Rate of pulmonary imageological improvement
Time frame: Up to 30 days
Rate of normalization of vital signs
Time frame: 7 days
Rate of normalization of inflammatory index of pneumonia
Time frame: 7 days
Safety assessment: adverse events
Time frame: Up to 30 days after first dose
Cost-effectiveness ratio
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Background: PubMed 29757717Koo 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.
- Background: PubMed 32053470Pan 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.
- Background: PubMed 30551404Wang 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.
- Background: PubMed 7249508Naranjo 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.
- Background: PubMed 18095744Agbabiaka 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.
- Background: PubMed 8995086Fine 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.
- Background: PubMed 20660689van 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Beijing Grand Johamu Pharmaceutical Company, Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cough-related symptoms improvement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002192, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.