NCT06286007

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 784 (estimated)
• Sponsor: Hospital Clinico Universitario de Santiago · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Pertussis
• RSV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PCR	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.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-07-31
• Completion: 2026-07-01
• First posted: 2024-02-29
• Last updated: 2024-03-01

Locations

1 site across 1 country: Spain