Omalizumab's dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma

Phase 4

Not yet recruiting

Conditions: Asthma

Registration Number: 2025-520782-48-00

Lead Sponsor: Consorci Mar Parc De Salut De Barcelona

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 110

Inclusion 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.

Exclusion Criteria

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
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.		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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Consorci Mar Parc De Salut De Barcelona
🇪🇸
Barcelona, Spain
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
🇪🇸
Barcelona, Spain
Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
🇪🇸
Barcelona, Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
🇪🇸
Barcelona, Spain
Consorci Mar Parc De Salut De Barcelona
🇪🇸Barcelona, Spain
Pilar Ausin
Site contact
932483825
mpausin@psmar.car