NCT05870215Completed
Phenotyping Responses to Systemic Corticosteroids in the Management of Asthma Attacks
Phenotyping Responses to Systemic Corticosteroids in the Management of Asthma Attacks (PRISMA): Clinical and Translational Correlation to Point-Of-Care Biomarkers
Source: ClinicalTrials.gov · Last updated 21 Jun 2024
Brief summary (registry, in English)
This observational study compares the phenotypic variability (clinical and biological) in treatment response to systemic corticosteroids according to the blood eosinophil count and FeNO in physician-diagnosed ≥12-year-old asthmatics presenting with an asthma attack and healthy controls. Multimodal clinical and translational assessments will be performed on 50 physician-diagnosed, ≥12-year-old asthma patients presenting with an asthma attack and 12 healthy controls. These will include a blood eosinophil count, FeNO, and testing for airway infection (conventional sputum cultures and POC nasopharyngeal swabs). People with asthma will be assessed on day 0 and after a 7-day corticosteroid course, with in-home monitoring performed in between.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 78 (actual)
- First submitted
- 17 Apr 2023
- Start date
- 1 Sept 2022
- Primary completion date
- 18 Apr 2024
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Asthma
- NCT number
- NCT05870215
What you commit to
- Study type: Observational
- Participants enrolled: 78
- From 1 Sept 2022 to the primary completion date, 18 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Asthma treated with a monoclonal antibody or maintenance oral glucocorticosteroids
- Contraindication to oral corticosteroids use
Age
- Significant overlapping cardiopulmonary disease (including chronic obstructive pulmonary disease, defined as age \>40 years old AND persistent airflow limitation with FEV1/FVC\<0.7 AND \>10 pack-year smoking history (or alpha-1-antitrypsin deficiency))
Other
- Current smoking
- SARS-CoV-2-positive event
- Confounding immunological state
- Pregnancy
Who the study is looking for
- Patients ≥12 years old with physician-diagnosed asthma for \>6 months
- Experiencing an asthma attack with a patient and/or physician's decision to initiate a burst of systemic corticosteroids (but not yet started)
- Assessed within 24 hours on weekdays after a screening telephone call.
- For healthy volunteers: Non-atopic, non-smoking subjects with normal spirometry and no history of lung disease
Age in the registry: 12 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.