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

Recruiting

• Conditions: Asthma; Pertussis; RSV Infection

• Registration Number: NCT06286007
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Study Timeline

• Study Start: 2023-12-21
• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-07-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 784

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain