Asthma, Pertussis, RSV Infection
Conditions
Keywords
Asthma, Pertussis, RSV Infection, Exacerbations
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPCR
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.
Sponsors
Translational Research In Airway Diseases Group (TRIAD)
CIBER of Respiratory Diseases CIBERES
Complexo Hospitalario Universitario de A Coruña
Hospital de Galdakao
Hospital Universitario Doctor Peset
Hospital San Pedro de Alcantara
Hospital Universitario Marqués de Valdecilla
Hospital Universitario Vall d´Hebron
Universitat Autonoma de Barcelona
Universidade de Santiago de Compostela
Consortium for Biomedical Research in Epidemiology and Public Health
Hospital Universitario Virgen del Rocio
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
University Hospital Virgen de las Nieves
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital of Navarra
Hospital Universitario de Jerez de la Frontera
Hospital El Bierzo
Hospital Clinico Universitario San Cecilio
Hospital Donostia
Hospital Universitario Central de Asturias
Hospital Universitario de la Ribera
Hospital Costa del Sol
Hospital General Universitario Dr. Balmis
Hospital de Sagunto
Hospital Lluis Alcanyís de Xàtiva
Hospital Universitario Lucus Augusti
Hospital del Mar
Hospital Universitario Virgen de la Arrixaca
Hospital Clinic of Barcelona
Hospital Clinico Universitario de Santiago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Bordetella pertussis and RSV infections in adult patients with asthma, | 2 years | Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the seroprevalence of Bordetella pertussis in adult patients with asthma | 2 years | To describe the seroprevalence of Bordetella pertussis in adult patients aged with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test |
| To describe the seroprevalence of RSV in adult patients with asthma | 2 years | To describe the seroprevalence RSV in adult patients with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test |
| To evaluate the severity and control of the asthma caused by either BP or RSV infection | 2 years | To evaluate, on an annual basis, the severity and control of the asthma, with regards to acute laboratory-confirmed respiratory illness caused by either BP or RSV infection during the study, using Asthma Control Test (ACT) questionnaire |
Countries
Spain
Contacts
Primary ContactFrancisco-Javier GONZALEZ BARCALA, MD, PhD
Outcome results
None listed