Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

Last updated: February 29, 2024
Sponsor: Hospital Clinico Universitario de Santiago
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Asthma

Respiratory Syncytial Virus (Rsv)

Treatment

PCR

Clinical Study ID

NCT06286007
PRIPASCO-2023
  • Ages 18-99
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 therequirements 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 asthmaexacerbation and/or ARI symptoms occurring)
  • Patients who are able to provide written informed consent.

Exclusion

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 abuseat the time of being included in the study, or an active oncological disease (patientsin treatment or follow-up for oncological disease) or pregnant women.
  • Patients treated with immunosuppressive or immunomodulating agents not related toasthma diagnosis. will be excluded.
  • Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have receivedan RSV (investigational) vaccine or medicine for any of the above, should be excludedfrom the study from the beginning. Patients that might be vaccinated in the upcomingyears, while the study is still ongoing, can enrol. However, from the moment theyreceive 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 beincluded in the analysis).
  • Patients vaccinated for B. Pertussis during the previous 12 months will be alsoexcluded.
  • Patients who plan to move during the study period will be excluded.

Study Design

Total Participants: 784
Treatment Group(s): 1
Primary Treatment: PCR
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago De Compostela, A Coruña 15706
    Spain

    Active - Recruiting

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