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

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

Official Title
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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

Conditions
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COPD Exacerbation, Pertussis

Intervention / Treatment
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* Procedure: Blood sample
* Other: Data collection
* Procedure: Throat swab


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe exacerbation of COPD<br>N = 250 | Procedure: Blood sample<br>* 2 ml venous blood was collected and separated into serum.<br>Other: Data collection<br>* Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination; Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics; Assess COPD using ABCD assessment tool.<br>Procedure: Throat swab<br>* 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.<br>|
| Mild and moderate exacerbations of COPD<br>N = 250 | Procedure: Blood sample<br>* 2 ml venous blood was collected and separated into serum.<br>Other: Data collection<br>* Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination; Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics; Assess COPD using ABCD assessment tool.<br>Procedure: Throat swab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the seroprevalence of Bordetella pertussis in COPD | According to anti-pertussis (anti-PT) antibody levels, assess the overall 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. | By comparing the nucleic acid and antibody levels of Bordetella pertussis to evaluate the antibody 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. | According to the level and pattern of different anti-pertussis antibodies (anti-PT, anti-FHA, anti-PRN, anti-FIM2, anti-FIM3), assess the subtype of Bordetella pertussis. | Day 0 of each subject at the time of enrollment. |