A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen

NCT ID: NCT04694430

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.

Detailed Description

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1. Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
2. To explore the relationship between pertussis infection and COPD exacerbation.

Conditions

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COPD Exacerbation Pertussis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Severe exacerbation of COPD

N = 250

Blood sample

Intervention Type PROCEDURE

2 ml venous blood was collected and separated into serum.

Data collection

Intervention Type OTHER

1. Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
2. Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;
3. Assess COPD using ABCD assessment tool.

Throat swab

Intervention Type PROCEDURE

Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue.

Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth.

Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time.

Mild and moderate exacerbations of COPD

N = 250

Blood sample

Intervention Type PROCEDURE

2 ml venous blood was collected and separated into serum.

Data collection

Intervention Type OTHER

1. Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
2. Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;
3. Assess COPD using ABCD assessment tool.

Throat swab

Intervention Type PROCEDURE

Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue.

Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth.

Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time.

Interventions

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Blood sample

2 ml venous blood was collected and separated into serum.

Intervention Type PROCEDURE

Data collection

1. Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
2. Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;
3. Assess COPD using ABCD assessment tool.

Intervention Type OTHER

Throat swab

Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue.

Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth.

Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Clinical diagnosis of acute COPD

Exclusion Criteria

\- Major diseases except COPD; Significant abnormality in laboratory examination; Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10\^9/L) within 4 weeks; Currently suffering from active tuberculosis; Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; Patients who have undergone lung resection.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lingwei Wang

Role: STUDY_DIRECTOR

Shenzhen People's Hospital

Locations

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Fuyong people's Hospital of Baoan District, Shenzhen

Shenzhen, , China

Site Status

General Hospital of Shenzhen University

Shenzhen, , China

Site Status

Longhua Branch of Shenzhen People's Hospital

Shenzhen, , China

Site Status

Nanshan District People's Hospital

Shenzhen, , China

Site Status

Peking university shenzhen hospital

Shenzhen, , China

Site Status

Shenzhen Bao'an District Central Hospital

Shenzhen, , China

Site Status

Shenzhen Bao'an District People's Hospital

Shenzhen, , China

Site Status

Shenzhen Hospital of Beijing University of traditional Chinese Medicine

Shenzhen, , China

Site Status

Shenzhen Hospital of Guangzhou University of traditional Chinese Medicine

Shenzhen, , China

Site Status

Shenzhen Hospital of Southern Medical University

Shenzhen, , China

Site Status

Shenzhen Hospital of the University of Hong Kong

Shenzhen, , China

Site Status

Shenzhen Longgang District Central Hospital

Shenzhen, , China

Site Status

Shenzhen Longgang District People's Hospital

Shenzhen, , China

Site Status

Shenzhen Longgang District Second People's Hospital

Shenzhen, , China

Site Status

Shenzhen Longgang District Third People's Hospital

Shenzhen, , China

Site Status

Shenzhen Longhua District Central Hospital

Shenzhen, , China

Site Status

Shenzhen Longhua District People's Hospital

Shenzhen, , China

Site Status

Shenzhen Luohu District People's Hospital

Shenzhen, , China

Site Status

Shenzhen People's Hospital

Shenzhen, , China

Site Status

Shenzhen Pingshan District Hospital of traditional Chinese Medicine

Shenzhen, , China

Site Status

Shenzhen Pingshan District People's Hospital

Shenzhen, , China

Site Status

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, , China

Site Status

Shenzhen Second People's Hospital

Shenzhen, , China

Site Status

Shenzhen TCM Hospital

Shenzhen, , China

Site Status

Shenzhen Yantian District People's Hospital

Shenzhen, , China

Site Status

South University of science and Technology Hospital

Shenzhen, , China

Site Status

The eighth Affiliated Hospital of Sun Yat sen University

Shenzhen, , China

Site Status

Countries

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China

Central Contacts

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Ronchan Chen

Role: CONTACT

18002222009

Facility Contacts

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Lingwei Wang

Role: primary

15914030269

Min Zhang

Role: primary

13823184488

References

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Wang M, Luo X, Xu S, Liu W, Ding F, Zhang X, Wang L, Liu J, Hu J, Wang W. Trends in smoking prevalence and implication for chronic diseases in China: serial national cross-sectional surveys from 2003 to 2013. Lancet Respir Med. 2019 Jan;7(1):35-45. doi: 10.1016/S2213-2600(18)30432-6. Epub 2018 Oct 25.

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Jia JH, Guo Q, Wan CM. [Resurgence and vaccine strategies of pertussis]. Zhonghua Er Ke Za Zhi. 2020 Aug 2;58(8):686-689. doi: 10.3760/cma.j.cn112140-20200116-00036. Chinese.

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Huang H, Zhu T, Gao C, Gao Z, Liu Y, Ding Y, Sun J, Guo L, Liu P, Chen D, Wang L, Wu S, Zhang Y. Epidemiological features of pertussis resurgence based on community populations with high vaccination coverage in China. Epidemiol Infect. 2015 Jul;143(9):1950-6. doi: 10.1017/S095026881400260X. Epub 2014 Oct 7.

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Other Identifiers

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WLW-COPD-Pertussis

Identifier Type: -

Identifier Source: org_study_id

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