Clinical trial NCT04694430: A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Pertussis
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute COPD in Shenzhen

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.

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.

Primary outcomes:
measure: Evaluation of the prevalence of pertussis among COPD
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the correlation between pertussis and COPD exacerbation
timeFrame: Day 0 of each subject at the time of enrollment.
Secondary outcomes:
measure: Evaluation of the seroprevalence of Bordetella pertussis in COPD
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the cut-off value for serological diagnosis of pertussis.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the subtype of bordetella pertussis.
timeFrame: Day 0 of each subject at the time of enrollment.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuyong people's Hospital of Baoan District, Shenzhen
city: Shenzhen
country: China
facility: General Hospital of Shenzhen University
city: Shenzhen
country: China
facility: Longhua Branch of Shenzhen People's Hospital
city: Shenzhen
country: China
facility: Nanshan District People's Hospital
city: Shenzhen
country: China
facility: Peking university shenzhen hospital
city: Shenzhen
country: China
facility: Shenzhen Bao'an District Central Hospital
city: Shenzhen
country: China
facility: Shenzhen Bao'an District People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Hospital of Beijing University of traditional Chinese Medicine
city: Shenzhen
country: China
facility: Shenzhen Hospital of Guangzhou University of traditional Chinese Medicine
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
city: Shenzhen
country: China
facility: Shenzhen Hospital of the University of Hong Kong
city: Shenzhen
country: China
facility: Shenzhen Longgang District Central Hospital
city: Shenzhen
country: China
facility: Shenzhen Longgang District People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Longgang District Second People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Longgang District Third People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Longhua District Central Hospital
city: Shenzhen
country: China
facility: Shenzhen Longhua District People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Luohu District People's Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Pingshan District Hospital of traditional Chinese Medicine
city: Shenzhen
country: China
facility: Shenzhen Pingshan District People's Hospital
city: Shenzhen
country: China
facility: Shenzhen Qianhai Shekou Free Trade Zone Hospital
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
city: Shenzhen
country: China
facility: Shenzhen TCM Hospital
city: Shenzhen
country: China
facility: Shenzhen Yantian District People's Hospital
city: Shenzhen
country: China
facility: South University of science and Technology Hospital
city: Shenzhen
country: China
facility: The eighth Affiliated Hospital of Sun Yat sen University
Study officials:
affiliation: Shenzhen People's Hospital
name: Lingwei Wang
role: STUDY_DIRECTOR
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