A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia

Sponsor
Beijing Grand Johamu Pharmaceutical Company, Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05002192
Collaborator
(none)
10,000
7
28
1428.6
51.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule
  • Drug: Ambroxol injection
  • Drug: Other oral mucolytic drugs

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule
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.

Drug: Other oral mucolytic drugs
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.

Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort

Drug: Ambroxol injection
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.

Drug: Ambroxol injection
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

Drug: Other oral mucolytic drugs
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort

AMB_ONLY

Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.

Drug: Ambroxol injection
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

Outcome Measures

Primary Outcome Measures

  1. Rate of cough-related symptoms improvement [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.

Secondary Outcome Measures

  1. Rate of overal cure and improvement in pneumonia treatment [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.

  2. Hospitalization length of stay [Up to 30 days]

    The mean hospitalization length of stay in every group is analyzed according the discharge summaries.

  3. Rate of pulmonary imageological improvement [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.

  4. Rate of normalization of vital signs [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.

  5. Rate of normalization of inflammatory index of pneumonia [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

  6. Safety assessment: adverse events [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.

  7. Cost-effectiveness ratio [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients with community-acquired pneumonia

  2. Inpatients from 2017 to 2019

  3. Regardless of age and gender

Exclusion Criteria:
  1. Patients diagnosed with hospital-acquired pneumonia

  2. Patients who take two or more oral mucolytics

  3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Peoples Hospital Beijing Beijing China 100044
2 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080
3 The First Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong China 510120
4 Shenzhen Second People's Hospital Shenzhen Guangdong China 518037
5 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071
6 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200020
7 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Beijing Grand Johamu Pharmaceutical Company, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Beijing Grand Johamu Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier:
NCT05002192
Other Study ID Numbers:
  • YD_SMQD_ELP_202009
First Posted:
Aug 12, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021