Omalizumab's dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma
Key facts
- Where
- Barcelona, SpanyolországSee the 4 sites
- Phase
- 4. fázis
Where in Spanyolország
- Consorci Mar Parc De Salut De BarcelonaBarcelona, SpanyolországToborzás még nem indult
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I SunyerBarcelona, SpanyolországToborzás még nem indult
- Fundació Hospital Universitari Vall d'Hebron - Institut de RecercaBarcelona, SpanyolországToborzás még nem indult
- Instituto De Investigacion En Ciencias De La Salud Germans Trias I PujolBarcelona, SpanyolországToborzás még nem indult
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
- Consorci Mar Parc De Salut De Barcelona
- Trial code
- EU 2025-520782-48-00
- Record updated
- 2025. január 30.
- Original description
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.Read full original descriptionShow less
Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
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.
Inclusion: 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.
Exclusion: 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); Those patients who do not keep the inclusion criteria (see inclusion criteria); Don't consent of legal tutor.