Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 784
- 试验地点
- 1
- 主要终点
- Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
研究概览
简要总结
The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
详细描述
The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
Depending on the symptoms presented and date of symptom onset, For pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age 18 years and over)
- •Diagnosed with asthma at least one year prior to the date of enrolment.
- •Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and/or ARI symptoms occurring)
- •Patients who are able to provide written informed consent.
排除标准
- •Patients with a prior history of pertussis in the last 12 months
- •Patients with ARI within the 2 weeks prior to enrolment
- •Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women.
- •Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded.
- •Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis).
- •Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded.
- •Patients who plan to move during the study period will be excluded.
结局指标
主要结局
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
时间窗: 2 years
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test
次要结局
- To describe the seroprevalence of Bordetella pertussis in adult patients with asthma(2 years)
- To evaluate the severity and control of the asthma caused by either BP or RSV infection(2 years)
- To describe the seroprevalence of RSV in adult patients with asthma(2 years)
研究者
Francisco Javier González Barcala
Respiratory Medicine Specialist
Hospital Clinico Universitario de Santiago