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

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Other oral mucolytic drugs; Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule; Drug: Ambroxol injection

• Registration Number: NCT05002192
• Lead Sponsor: Beijing Grand Johamu Pharmaceutical Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EXP_ONLY	Other oral mucolytic drugs	Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
ELP+AMB	Eucalyptol, Limonene and Pinene Enteric Soft Capsule	Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
ELP_ONLY	Eucalyptol, Limonene and Pinene Enteric Soft Capsule	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.
EXP+AMB	Other oral mucolytic drugs	Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
ELP+AMB	Ambroxol injection	Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
EXP+AMB	Ambroxol injection	Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
AMB_ONLY	Ambroxol injection	Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
Hospitalization length of stay	Up to 30 days	The mean hospitalization length of stay in every group is analyzed according the discharge summaries.
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
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.

Trial Locations

Locations (7)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Peking University Peoples Hospital; 🇨🇳 Beijing, Beijing, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The First Affiliated Hospital Of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China