Clinical trial • Phase IV • Immunology|Respiratory

Omalizumab for Asthma|Allergic severe asthma

Phase IV trial of Omalizumab for Asthma|Allergic severe asthma. 110 participants.

Overview

Trial Therapeutic Area
Immunology|Respiratory
Trial Disease
Asthma|Allergic severe asthma
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-01-2025
First CTIS Authorization Date
30-01-2025

Trial design

Phase IV trial across 4 sites in Spain.

Target Sample Size
110

Eligibility

Recruits 110 Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study..

Vulnerable Population
Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study.

Inclusion criteria

  • {"criterion_text":"-Patients: 18 - 80 years."}
  • {"criterion_text":"-Before 6-month, the patient must have kept the follow inclusion criteria: Omalizumab adherence: 100%."}
  • {"criterion_text":"-Before 6-month, the patient must have kept the follow inclusion criteria: ACT ≥19."}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-Before 6-month, the patient must have kept the follow inclusion criteria: Don't make use of oral corticosteroids."}
  • {"criterion_text":"-Before 6-month, the patient must have kept the follow inclusion criteria: Lack of emergency visits or hospital admissions."}
  • {"criterion_text":"-Patients shall go or shall answer to in-person or telephonic visits."}
  • {"criterion_text":"-Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study."}

Exclusion criteria

  • {"criterion_text":"-Those patients who do not keep the inclusion criteria (see inclusion criteria)."}
  • {"criterion_text":"-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)."}
  • {"criterion_text":"-Don't consent of legal tutor."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-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.","definition_or_measurement_approach":"Assessed by the lack of crisis, quality of life and lung function."}

Recruitment

Planned Sample Size
110
Recruitment Window Months
49
Consent Approach
Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study. (Subject information and informed consent form document available: "HIP-CI_omalizuamb_v3_20220609")

Geography

Total Number Of Sites
4
Total Number Of Participants
110

Spain

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
30-01-2025
Processing Time Days
8
Number Of Sites
4
Number Of Participants
110

Sites

Site Name
Consorci Mar Parc De Salut De Barcelona
Department Name
Pneumology
Principal Investigator Name
Pilar Ausin
Principal Investigator Email
mpausin@psmar.car
Contact Person Name
Pilar Ausin
Contact Person Email
mpausin@psmar.car
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Alergology
Principal Investigator Name
Olga Luengo
Principal Investigator Email
oluengo@vhebron.net
Contact Person Name
Olga Luengo
Contact Person Email
oluengo@vhebron.net
Site Name
Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
Department Name
Alergology
Principal Investigator Name
María Basagaña
Principal Investigator Email
alergia.germanstrias@gencat.cat
Contact Person Name
María Basagaña
Site Name
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Department Name
Alergology
Principal Investigator Name
Pilar Martínez
Principal Investigator Email
PMARTINE@clinic.cat
Contact Person Name
Pilar Martínez
Contact Person Email
PMARTINE@clinic.cat

Sponsor

Primary sponsor

Full Name
Consorci Mar Parc De Salut De Barcelona
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Xolair 75 mg solution for injection in pre-filled syringe
Active Substance
Omalizumab
Modality
Monoclonal antibody
Routes Of Administration
CUTANEOUS USE
Route
CUTANEOUS USE
Authorisation Status
Marketing authorisation present (EU/1/05/319/020)
Maximum Dose
600 mg
Investigational Product Name
Xolair 150 mg solution for injection in pre-filled syringe
Active Substance
Omalizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Marketing authorisation present (EU/1/05/319/024)
Maximum Dose
600 mg

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