NCT05144087Active, not recruiting
The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma
Source: ClinicalTrials.gov · Last updated 19 Feb 2025
Brief summary (registry, in English)
The IRIS study aims to investigate the way Mepolizumab affects the structure of the airway cells in patients with Severe Eosinophilic Asthma and how the immune function of these cells changes with treatment. The aim is to take samples of cells from the airways before starting Mepolizumab and after 6 months of treatment. These samples will be taken during a bronchoscopy (a camera test looking into the lungs) and we will analyse these cells in the laboratory. These investigations will allow us to better understand how Mepolizumab affects the cells within the airways.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 18 (estimated)
- First submitted
- 3 Sept 2021
- Start date
- 25 May 2022
- Primary completion date
- 30 May 2024
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Asthma
- NCT number
- NCT05144087
What you commit to
- Study type: Observational
- Planned participants: 18
- From 25 May 2022 to the primary completion date, 30 May 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
- On maintenance daily oral steroids, asthma immune modulators
- Alcohol or recreational drug abuse
- Previous bronchial thermoplasty
- Previous treatment with biological therapy
- Previously unable to tolerate a bronchoscopy
Other illness
- Known clinically significant respiratory disorder such as bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis
- History of psychiatric, medical or surgical disorders that in the opinion of the chief investigator may interfere with undergoing a bronchoscopy or may compromise study completion or data collection
- Current malignancy
- Current or recent (within the last 12 weeks) infection with SARS-CoV-2
Other
- On long-term systemic antibiotics or antifungal treatment
- Current smoker or ex-smoker with \>10 pack year smoking history
- Currently pregnant or planning pregnancy within the treatment period or breast-feeding
- Diagnosis of immunodeficiency requiring treatment
- Unable to provide written informed consent
Who the study is looking for
- Diagnosis of Severe Eosinophilic Asthma (as per Southampton Severe Asthma MDT and based on ATS/ERS consensus criteria)
- Approved for treatment with Mepolizumab by Southampton Severe Asthma MDT (in accordance with NICE TA 431)
- Blood eosinophil count is ≥0.3 x109cells/L in preceding 12 months
- ≥4 asthma exacerbations needing systemic steroids in the preceding 12 months
- Age ≥18 years
- Able to provide written informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept 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 |
|---|---|---|---|
| NIHR Clinical Research Facility Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.