Understanding how Pertussis and RSV affect asthma severity
Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
This study is trying to see how infections from whooping cough and RSV affect asthma symptoms in adults over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 784 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hospital Clinico Universitario de Santiago Academic / other |
| Locations | 1 site (Santiago de Compostela, A Coruña) |
| Trial ID | NCT06286007 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the annual incidence of Bordetella pertussis and RSV infections in adults with asthma. Participants aged 18 and over will be monitored for asthma exacerbations and symptoms of acute respiratory infections over a two-year period. The study will utilize PCR testing to identify infections at specific time points after symptom onset. Conducted across 35 centers in Spain, the study will gather valuable data on the impact of these infections on asthma control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a diagnosis of asthma for at least one year.
Not a fit: Patients with recent respiratory infections or other significant respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for asthma patients by understanding the role of infections in exacerbations.
How similar studies have performed: While similar studies have explored the impact of infections on asthma, this specific approach focusing on pertussis and RSV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santiago de Compostela, A Coruña
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
Study contacts
- Study coordinator: Francisco-Javier GONZALEZ BARCALA, MD, PhD
- Email: francisco.javier.gonzalez.barcala@sergas.es
- Phone: +34607819141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.