NCT06286007 Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
| NCT ID | NCT06286007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinico Universitario de Santiago |
| Condition | Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 784 participants |
| Start Date | 2023-12-21 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 784 participants in total. It began in 2023-12-21 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Francisco-Javier GONZALEZ BARCALA, MD, PhD
✉ francisco.javier.gonzalez.barcala@sergas.es📞 +34607819141
Frequently Asked Questions
Who can join the NCT06286007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06286007 currently recruiting?
Yes, NCT06286007 is actively recruiting participants. Contact the research team at francisco.javier.gonzalez.barcala@sergas.es for enrollment information.
Where is the NCT06286007 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain.
Who is sponsoring the NCT06286007 clinical trial?
NCT06286007 is sponsored by Hospital Clinico Universitario de Santiago. The trial plans to enroll 784 participants.
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