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Not yet taking people in SpainPhase 4

Testing a lower omalizumab dose in adults with severe allergic asthma

Tests a lower omalizumab dose in adults with severe allergic asthma.

Key facts

Who runs it
Consorci Mar Parc De Salut De Barcelona
Where
Barcelona, SpainSee the 4 sites
Registry title
Omalizumab's dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma
Status
Not yet recruiting
Phase
Phase 4
People taking part
110 people, planned
Started
9 Mar 2022
Planned end
24 Mar 2026
Type of study
Interventional
Record updated
30 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with allergic severe asthma who are stable on omalizumab. It tests whether a 50% lower omalizumab dose keeps asthma as well controlled.

Age
18 - 80 years
Sex
All sexes can join.
Disease stage
Allergic severe asthma that has been stable for the last 6 months: ACT of 19 or more, stable FEV1 (>80%) or the person's own best value, no emergency visits or hospital stays.
Earlier treatment
Took omalizumab for the last 6 months with 100% adherence. No oral corticosteroids in that time.

Main reasons for not taking part

  • Does not meet the stability criteria above
  • Takes omalizumab for another disease
  • Takes immunosuppressors or oral corticosteroids
  • Has another chronic lung disease (such as cystic fibrosis, COPD, cancer or an immunodeficiency disease)
  • Legal guardian does not consent, where one is needed

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Those patients who do not keep the inclusion criteria (see inclusion criteria)
  • Don't consent of legal tutor

Where in Spain

  • Consorci Mar Parc De Salut De BarcelonaBarcelona, SpainNot yet recruiting
  • Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I SunyerBarcelona, SpainNot yet recruiting
  • Fundació Hospital Universitari Vall d'Hebron - Institut de RecercaBarcelona, SpainNot yet recruiting
  • Instituto De Investigacion En Ciencias De La Salud Germans Trias I PujolBarcelona, SpainNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
Plain-language title
Testing a lower omalizumab dose in adults with severe allergic asthmaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 11 November 2026.
Record updated
30 January 2025