2025-520782-48-00Not yet recruitingPhase 4
Omalizumab's dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma
Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 9 Mar 2022
- Lead sponsor
- Consorci Mar Parc De Salut De Barcelona
- Diseases
- Asthma
- EU CT number
- 2025-520782-48-00
- EudraCT number
- 2021-005578-24
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Excluded patients: omalizumab for the treatment of other diseases, use of immunosuppressors or oral corticosteroids and those who have a diagnostic of other chronic respiratory diseases (such as cystic fibrosis, COPD, cancer, or immunodeficiency disease).
Other
- Those patients who do not keep the inclusion criteria (see inclusion criteria).
- Don't consent of legal tutor.
Who the study is looking for
- Patients: 18 - 80 years.
- Before 6-month, the patient must have kept the follow inclusion criteria: Omalizumab adherence: 100%.
- Before 6-month, the patient must have kept the follow inclusion criteria: ACT ≥19.
- Before 6-month, the patient must have kept the follow inclusion criteria: Stable FEV1 (>80%) or the best value of those patients that don't reach the 80% due to previous deterioration lung function.
- Before 6-month, the patient must have kept the follow inclusion criteria: Don't make use of oral corticosteroids.
- Before 6-month, the patient must have kept the follow inclusion criteria: Lack of emergency visits or hospital admissions.
- Patients shall go or shall answer to in-person or telephonic visits.
- Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca | Barcelona | Spain | Not yet recruiting |
| Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer | Barcelona | Spain | Not yet recruiting |
| Consorci Mar Parc De Salut De Barcelona | Barcelona | Spain | Not yet recruiting |
| Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol | Barcelona | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.