The RHINOME study
Key facts
- Where
- Copenhagen Nv, DániaSee the site
- Phase
- 4. fázis
Where in Dánia
- Region HovedstadenCopenhagen Nv, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2026-527032-14-00
- Record updated
- 2026. augusztus 10.
- Original description
To compare epithelial TSLP protein induction following viral mimic stimulation in patients with severe asthma with and without chronic rhinosinusitis.Read full original descriptionShow less
To compare epithelial TSLP protein induction following viral mimic stimulation in patients with severe asthma with and without chronic rhinosinusitis.
Inclusion: Outpatient recruitment pool: 1. Diagnosed with severe asthma; Outpatient recruitment pool: 2. Adult ≥18 years; Outpatient recruitment pool: 3. Clinical decision to initiate tezepelumab for severe asthma after meeting licensing, local and national guidelines; Outpatient recruitment pool: 4. Able to give valid written informed consent, and compliant with study procedures and study visits; 3TR-ABC recruitment pool: 1. 3TR-ABC participant at the Bispebjerg site who completed 1-year follow-up visit; 3TR-ABC recruitment pool: 2. Specific bio-sampling for nasal and/or bronchial epithelial cells (NECs and/or BECs) at bio-naïve baseline; 3TR-ABC recruitment pool: 3. Able to give valid written informed consent.
Exclusion: Outpatient recruitment pool: 4. Other clinically significant medical disease or uncontrolled concomitant disease likely, in the investigator's opinion, to require a change in therapy or to impair the ability to participate; Outpatient recruitment pool: 1. Known hypersensitivity to the active substance or any excipient in tezepelumab; Outpatient recruitment pool: 2. Participation in an interventional clinical trial within 3 months of the baseline visit, or receipt of any investigational medicinal product within 3 months or 5 half-lives, whichever is longer; Outpatient recruitment pool: 3. Participation in other studies that, in the investigator's view, will impact the study outcomes; Outpatient recruitment pool: 5. Unwilling or unable, in the investigator's opinion, to participate in study procedures and assessments; 3TR-ABC recruitment pool: 1. Known quality issues with airway samples making them insufficient for planned key analyses; 3TR-ABC recruitment pool: 2. Any participant who has specifically withdrawn their consent for future use of samples in the 3TR-ABC study; Outpatient recruitment pool: 6. Known or suspected pregnancy or breastfeeding, at the baseline (screening) visit. In individuals of childbearing potential, pregnancy is ruled out by a negative urine pregnancy test before inclusion.