COPD Exacerbation, Pertussis
Conditions
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.
Interventions
PROCEDUREBlood sample
2 ml venous blood was collected and separated into serum.
OTHERData 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.
PROCEDUREThroat 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.
Sponsors
Shenzhen People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the prevalence of pertussis among COPD | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the seroprevalence of Bordetella pertussis in COPD | Day 0 of each subject at the time of enrollment. | According to anti-pertussis (anti-PT) antibody levels, assess the overall seroprevalence of Bordetella pertussis in COPD. |
| Evaluation of the cut-off value for serological diagnosis of pertussis. | Day 0 of each subject at the time of enrollment. | By comparing the nucleic acid and antibody levels of Bordetella pertussis to evaluate the antibody cut-off value for serological diagnosis of pertussis. |
| Evaluation of the subtype of bordetella pertussis. | Day 0 of each subject at the time of enrollment. | 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. |
Countries
China
Contacts
Primary ContactRonchan Chen
Outcome results
None listed