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

Asthma Clinical Trial

— PRIPASCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286007
• Other study ID #: PRIPASCO-2023
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Francisco-Javier GONZALEZ BARCALA, MD, PhD
• Phone: +34607819141
• Email: francisco.javier.gonzalez.barcala[@]sergas.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 784
• Est. completion date: July 1, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Pertussis
• Respiratory Syncytial Virus Infections
• RSV Infection
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña

Sponsors (32)

Lead Sponsor

Collaborator

Hospital Clinico Universitario de Santiago

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

Country where clinical trial is conducted

Spain, 

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Zeevat F, Luttjeboer J, Paulissen JHJ, van der Schans J, Beutels P, Boersma C, Postma MJ; RESCEU Investigators. Exploratory Analysis of the Economically Justifiable Price of a Hypothetical RSV Vaccine for Older Adults in the Netherlands and the United Kingdom. J Infect Dis. 2022 Aug 12;226(Suppl 1):S102-S109. doi: 10.1093/infdis/jiab118. — View Citation

Zhang Y, Sakthivel SK, Bramley A, Jain S, Haynes A, Chappell JD, Hymas W, Lenny N, Patel A, Qi C, Ampofo K, Arnold SR, Self WH, Williams DJ, Hillyard D, Anderson EJ, Grijalva CG, Zhu Y, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Erdman DD. Serology Enhances Molecular Diagnosis of Respiratory Virus Infections Other than Influenza in Children and Adults Hospitalized with Community-Acquired Pneumonia. J Clin Microbiol. 2016 Dec 28;55(1):79-89. doi: 10.1128/JCM.01701-16. Print 2017 Jan. — View Citation

* Note: There are 71 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To describe the seroprevalence of Bordetella pertussis in adult patients with asthma	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
Secondary	To describe the seroprevalence of RSV in adult patients with asthma	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
Secondary	To evaluate the severity and control of the asthma caused by either BP or RSV infection	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

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