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Clinical Trials/NCT04694430
NCT04694430
Unknown
Not Applicable

A Integration of Respiratory Medicine and Prevention Multi-center Study to Determine the Prevalence and Influence of Pertussis on Chronic Obstructive Pulmonary Disease Exacerbation in Shenzhen by National Respiratory Diseases Clinical Medicine Research Center

Shenzhen People's Hospital27 sites in 1 country500 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
Shenzhen People's Hospital
Enrollment
500
Locations
27
Primary Endpoint
Evaluation of the prevalence of pertussis among COPD
Last Updated
5 years ago

Overview

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shenzhen People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Evaluation of the prevalence of pertussis among COPD

Time Frame: Day 0 of each subject at the time of enrollment.

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

Evaluation of the correlation between pertussis and COPD exacerbation

Time Frame: Day 0 of each subject at the time of enrollment.

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

Secondary Outcomes

  • Evaluation of the cut-off value for serological diagnosis of pertussis.(Day 0 of each subject at the time of enrollment.)
  • Evaluation of the seroprevalence of Bordetella pertussis in COPD(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 Sites (27)

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