Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control (PRIPASCO)

February 29, 2024 updated by: Francisco Javier González Barcala, Hospital Clinico Universitario de Santiago

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

784

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
Time Frame: 2 years
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the severity and control of the asthma caused by either BP or RSV infection
Time Frame: 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
2 years
To describe the seroprevalence of Bordetella pertussis in adult patients with asthma
Time Frame: 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
2 years
To describe the seroprevalence of RSV in adult patients with asthma
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Universitat Autonoma de Barcelona
Hospital del Mar
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Universitario Central de Asturias
Hospital Universitario Doctor Peset
Hospital Costa del Sol
Hospital Universitario Marqués de Valdecilla
Hospital San Pedro de Alcantara
Hospital El Bierzo
Complexo Hospitalario Universitario de A Coruña
Hospital Clinico Universitario San Cecilio
Hospital Universitario Donostia
Hospital Clínico Universitario Virgen de la Arrixaca
Hospital Universitario Lucus Augusti
University Hospital Virgen de las Nieves
Hospital Universitario de Navarra
Hospital de Sagunto
Hospital de Galdakao
Hospital Universitario Vall d´Hebron
Universidade de Santiago de Compostela
Hospital Universitario Virgen del Rocio
Hospital de La Princesa
Hospital Universitario de Jerez de la Frontera
Hospital Universitario de la Ribera
Hospital General Universitario Dr. Balmis
Hospital Lluis Alcanyís de Xàtiva
Translational Research In Airway Diseases Group (TRIAD)
CIBER of Respiratory Diseases CIBERES
Consortium for Biomedical Research in Epidemiology and Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIPASCO-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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