Omalizumab’s dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma.
- Conditions
- MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-005578-24-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 55
Patients: 18 - 80 years.
Before 6-month, the patient must have kept the follow inclusion criteria:
- Omalizumab adherence: 100%.
- ACT =19.
- Stable FEV1 (>80%) or the best value of those patients that don’t reach the 80% due to previous deterioration lung function.
- Don’t make use of oral corticosteroids.
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method