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

Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005578-24-ES

Enrollment

Registered

2022-02-02

Start date

2022-03-10

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 21.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855

Interventions

Trade Name: Xolair solución inyectable en jeringa precargada. Pharmaceutical Form: Solution for infusion in pre-filled syringe INN or Proposed INN: Omalizumab CAS Number: 242138-07-4 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: - To make a cost minimization analysis of intervention: last vs next year. - To determine a correlation between probable prognostic factors with a good response to the dose reduction;Primary end point(s): Exacerbation. It is defined as a decline of basal clinical state of patient. As a result, the patient should take specific drugs to resolve the situation. It is evaluated by dyspnoea, sibilant breath, the increase of respiratory frequency, the need of systemic corticosteroids, decline of FEV1, emergency visits and/or hospital admission. If one of these situations are developed, the intervention will be considered a negative result. Each exacerbation will always verify that is a direct cause of reduction doses, discarding others potential factors.;Timepoint(s) of evaluation of this end point: From the first intervention, exacerbation will be evaluated each 4 weeks to the week 48 by telephonic call and a day hospital visit, alternately. After that, exacerbation will be evaluated each 4 months in the follow-up period.	—

Measure

Time frame

Main Objective: 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 Objective: - To make a cost minimization analysis of intervention: last vs next year. - To determine a correlation between probable prognostic factors with a good response to the dose reduction;Primary end point(s): Exacerbation. It is defined as a decline of basal clinical state of patient. As a result, the patient should take specific drugs to resolve the situation. It is evaluated by dyspnoea, sibilant breath, the increase of respiratory frequency, the need of systemic corticosteroids, decline of FEV1, emergency visits and/or hospital admission. If one of these situations are developed, the intervention will be considered a negative result. Each exacerbation will always verify that is a direct cause of reduction doses, discarding others potential factors.;Timepoint(s) of evaluation of this end point: From the first intervention, exacerbation will be evaluated each 4 weeks to the week 48 by telephonic call and a day hospital visit, alternately. After that, exacerbation will be evaluated each 4 months in the follow-up period.

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Secondary

Measure	Time frame
Secondary end point(s): Other secondary endpoints included: baseline demographic and clinical data, ACT total score, change from baseline in FEV1, blood eosinophil and lymphocytes count and the need of inhaled or systemic corticosteroids and rescue medication. Others as: FeNO, IgE, FcREI of basophils and omalizumab plasmatic concentration. Economical cost of drug dispensation will be collected by registering dispensations, hospital admissions, emergency visit and requeriment of injectable corticosteroids.;Timepoint(s) of evaluation of this end point: - Baseline demographic and clinical data will be only measured in the inclusion visit. - ACT, FEV, the need of inhaled or systemic corticosteroids and rescue medication will be valued every 4 weeks. - Blood eosinophil and lymphocytes count and FeNO will be measured in every presential visit. - FcREI of basophils and IgE count will be determined in inclusion, basal and final visit and week 4, 24,28 and 48. - Plasmatic concentration will be collected in basal and final visit and week 24 and 48. - The cost of omalizumab will be calculated at the end of the study.	—

Measure

Time frame

Secondary end point(s): Other secondary endpoints included: baseline demographic and clinical data, ACT total score, change from baseline in FEV1, blood eosinophil and lymphocytes count and the need of inhaled or systemic corticosteroids and rescue medication. Others as: FeNO, IgE, FcREI of basophils and omalizumab plasmatic concentration. Economical cost of drug dispensation will be collected by registering dispensations, hospital admissions, emergency visit and requeriment of injectable corticosteroids.;Timepoint(s) of evaluation of this end point: - Baseline demographic and clinical data will be only measured in the inclusion visit. - ACT, FEV, the need of inhaled or systemic corticosteroids and rescue medication will be valued every 4 weeks. - Blood eosinophil and lymphocytes count and FeNO will be measured in every presential visit. - FcREI of basophils and IgE count will be determined in inclusion, basal and final visit and week 4, 24,28 and 48. - Plasmatic concentration will be collected in basal and final visit and week 24 and 48. - The cost of omalizumab will be calculated at the end of the study.

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Countries

Spain

Contacts

Public ContactHospital del Mar

Consorci Mar Parc de Salut de Barcelona

62915@psmar.cat0034932485074

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026