Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorHospital Clinico Universitario de Santiago
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Consecutive adult patients (18 years and over) with asthma diagnosed at least one year before will be enrolled from the asthma clinics of selected hospitals. Every group (at each participating site) should include 35% of patients over 60 years old considering that this age-group has higher risk of infection and worse prognosis than the younger one.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PCR
Diagnostic testDepending 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test
Time frame
2 yearsSecondary outcomes
1
To describe the seroprevalence of Bordetella pertussis in adult patients with asthma
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
Time frame
2 years2
To describe the seroprevalence of RSV in adult patients with asthma
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
Time frame
2 years3
To evaluate the severity and control of the asthma caused by either BP or RSV infection
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
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Clinico Universitario de Santiago
Lead sponsor
Translational Research In Airway Diseases Group (TRIAD)
Collaborator
CIBER of Respiratory Diseases CIBERES
Collaborator
Complexo Hospitalario Universitario de A Coruña
Collaborator
Hospital de Galdakao
Collaborator
Hospital Universitario Doctor Peset
Collaborator
Hospital San Pedro de Alcantara
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator
Hospital Universitario Vall d´Hebron
Collaborator
Universitat Autonoma de Barcelona
Collaborator
Universidade de Santiago de Compostela
Collaborator
Consortium for Biomedical Research in Epidemiology and Public Health
Collaborator
Hospitales Universitarios Virgen del Rocío
Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborator
University Hospital Virgen de las Nieves
Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital of Navarra
Collaborator
Hospital Universitario de Jerez de la Frontera
Collaborator
Hospital El Bierzo
Collaborator
Hospital Clinico Universitario San Cecilio
Collaborator
Hospital Donostia
Collaborator
Hospital Universitario Central de Asturias
Collaborator
Hospital Universitario de la Ribera
Collaborator
Hospital Costa del Sol
Collaborator
Hospital General Universitario Dr. Balmis
Collaborator
Hospital de Sagunto
Collaborator
Hospital Lluis Alcanyís de Xàtiva
Collaborator
Hospital Universitario Lucus Augusti
Collaborator
Hospital del Mar
Collaborator
Hospital Universitario Virgen de la Arrixaca
Collaborator
Hospital Clinic of Barcelona
Collaborator
Source ClinicalTrials.gov