Omalizumab's dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma
EU CTIS ID: 2025-520782-48-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Those patients who do not keep the inclusion criteria (see inclusion criteria).
- 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).
- Don't consent of legal tutor.
See the full eligibility criteria
- 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.
- Those patients who do not keep the inclusion criteria (see inclusion criteria).
- 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).
- Don't consent of legal tutor.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.