NCT04694430

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

27 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

December 24, 2020

Last Update Submit

January 4, 2021

Conditions

COPD ExacerbationPertussis

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the prevalence of pertussis among COPD

    According to the positive rate of bordetella pertussis nucleic acid, evaluate the prevalence of pertussis in COPD.

    Day 0 of each subject at the time of enrollment.

  • Evaluation of the correlation between pertussis and COPD exacerbation

    Evaluate the correlation between pertussis infection and COPD exacerbation by pertussis positive rate and exacerbation degree.

    Day 0 of each subject at the time of enrollment.

Secondary Outcomes (3)

  • Evaluation of the seroprevalence of Bordetella pertussis in COPD

    Day 0 of each subject at the time of enrollment.

  • Evaluation of the cut-off value for serological diagnosis of pertussis.

    Day 0 of each subject at the time of enrollment.

  • Evaluation of the subtype of bordetella pertussis.

    Day 0 of each subject at the time of enrollment.

Study Arms (2)

Severe exacerbation of COPD

N = 250

Procedure: Blood sampleOther: Data collectionProcedure: Throat swab

Mild and moderate exacerbations of COPD

N = 250

Procedure: Blood sampleOther: Data collectionProcedure: Throat swab

Interventions

Blood samplePROCEDURE

2 ml venous blood was collected and separated into serum.

Mild and moderate exacerbations of COPDSevere exacerbation of COPD
Data collectionOTHER

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.

Mild and moderate exacerbations of COPDSevere exacerbation of COPD
Throat swabPROCEDURE

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 COPDSevere exacerbation of COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute COPD in Shenzhen

You may qualify if:

  • \- Clinical diagnosis of acute COPD

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Fuyong people's Hospital of Baoan District, Shenzhen

Shenzhen, China

Location

General Hospital of Shenzhen University

Shenzhen, China

Location

Longhua Branch of Shenzhen People's Hospital

Shenzhen, China

Location

Nanshan District People's Hospital

Shenzhen, China

Location

Peking university shenzhen hospital

Shenzhen, China

Location

Shenzhen Bao'an District Central Hospital

Shenzhen, China

Location

Shenzhen Bao'an District People's Hospital

Shenzhen, China

Location

Shenzhen Hospital of Beijing University of traditional Chinese Medicine

Shenzhen, China

Location

Shenzhen Hospital of Guangzhou University of traditional Chinese Medicine

Shenzhen, China

Location

Shenzhen Hospital of Southern Medical University

Shenzhen, China

Location

Shenzhen Hospital of the University of Hong Kong

Shenzhen, China

Location

Shenzhen Longgang District Central Hospital

Shenzhen, China

Location

Shenzhen Longgang District People's Hospital

Shenzhen, China

Location

Shenzhen Longgang District Second People's Hospital

Shenzhen, China

Location

Shenzhen Longgang District Third People's Hospital

Shenzhen, China

Location

Shenzhen Longhua District Central Hospital

Shenzhen, China

Location

Shenzhen Longhua District People's Hospital

Shenzhen, China

Location

Shenzhen Luohu District People's Hospital

Shenzhen, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

Shenzhen Pingshan District Hospital of traditional Chinese Medicine

Shenzhen, China

Location

Shenzhen Pingshan District People's Hospital

Shenzhen, China

Location

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, China

Location

Shenzhen Second People's Hospital

Shenzhen, China

Location

Shenzhen TCM Hospital

Shenzhen, China

Location

Shenzhen Yantian District People's Hospital

Shenzhen, China

Location

South University of science and Technology Hospital

Shenzhen, China

Location

The eighth Affiliated Hospital of Sun Yat sen University

Shenzhen, China

Location

Related Publications (10)

  • Manian P. Chronic obstructive pulmonary disease classification, phenotypes and risk assessment. J Thorac Dis. 2019 Sep;11(Suppl 14):S1761-S1766. doi: 10.21037/jtd.2019.05.10.

    PMID: 31632753BACKGROUND

  • Santus P, Pecchiari M, Tursi F, Valenti V, Saad M, Radovanovic D. The Airways' Mechanical Stress in Lung Disease: Implications for COPD Pathophysiology and Treatment Evaluation. Can Respir J. 2019 Sep 5;2019:3546056. doi: 10.1155/2019/3546056. eCollection 2019.

    PMID: 31583033BACKGROUND

  • Canepa M, Franssen FME, Olschewski H, Lainscak M, Bohm M, Tavazzi L, Rosenkranz S. Diagnostic and Therapeutic Gaps in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2019 Oct;7(10):823-833. doi: 10.1016/j.jchf.2019.05.009. Epub 2019 Sep 11.

    PMID: 31521680BACKGROUND

  • Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.

    PMID: 23245604BACKGROUND

  • 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.

    PMID: 30482646BACKGROUND

  • 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.

    PMID: 32842393BACKGROUND

  • 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.

    PMID: 25286969BACKGROUND

  • Huang HT, Gao ZG, Liu Y, Sun J, Liu P, Wang LJ, Li Y, Zhang J, Zhang Y. [Epidemiology of pertussis in adults and related factors in Tianjin, 2005-2014]. Zhonghua Liu Xing Bing Xue Za Zhi. 2016 May;37(5):678-81. doi: 10.3760/cma.j.issn.0254-6450.2016.05.018. Chinese.

    PMID: 27188361BACKGROUND

  • Wang Y, Xu C, Ren J, Zhao Y, Li Y, Wang L, Yao S. The long-term effects of meteorological parameters on pertussis infections in Chongqing, China, 2004-2018. Sci Rep. 2020 Oct 14;10(1):17235. doi: 10.1038/s41598-020-74363-8.

    PMID: 33057239BACKGROUND

  • Wang H, Zheng Y, de Groot R, Yang Y, Diavatopoulos DA, Chen Y, de Jonge MI, Deng J. High prevalence of Bordetella pertussis in young hospitalized infants with acute respiratory infection in the south of China: age- and season-dependent effects. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.009. Epub 2020 Jan 23. No abstract available.

    PMID: 31981637BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Throat swab, Peripheral blood

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen CollectionData Collection

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lingwei Wang

    Shenzhen People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Ronchan Chen

CONTACT

18002222009chenrc@vip.163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(27)