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

NCT06286007 | Recruiting

• 1 other identifier: PRIPASCO-2023
• Study Type: observational
• Target: 784
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma; Pertussis; RSV Infection

Keywords

Asthma; Pertussis; RSV Infection; Exacerbations

Outcome Measures

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

  2 years

Secondary Outcomes (3)

• To describe the seroprevalence of Bordetella pertussis in adult patients with asthma

  2 years

• To describe the seroprevalence of RSV in adult patients with asthma

  2 years

• To evaluate the severity and control of the asthma caused by either BP or RSV infection

  2 years

Interventions

PCR DIAGNOSTIC_TEST

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.

Also known as: Serology

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• 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
• Hospital Universitario Virgen del Rocio: 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

Study Sites (1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Related Publications (71)

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Related Links

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The PCR samples (in all sites) and serology samples (yearly serology) in all the patients that are still included in the study will be obtained in each research centre and then sent to the coordinating centre

MeSH Terms

Conditions

Asthma; Whooping Cough; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Central Study Contacts

Francisco-Javier GONZALEZ BARCALA, MD, PhD

CONTACT

+34607819141; francisco.javier.gonzalez.barcala@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Medicine Specialist

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 29, 2024
• Study Start: December 21, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

ES (1)