Overview
Sponsor-declared trial summary
Asthma
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.
Key facts
- Sponsor
- Consorci Mar Parc De Salut De Barcelona
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520782-48-00
- EudraCT number
- 2021-005578-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Therapy, Safety
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.
Conditions and MedDRA coding
Asthma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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 3
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Xolair 75 mg solution for injection in pre-filled syringe
PRD10950045 · Product
- Active substance
- Omalizumab
- Substance synonyms
- IGE-025A, SYN008
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03DX05 — OMALIZUMAB
- Marketing authorisation
- EU/1/05/319/020
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xolair 150 mg solution for injection in pre-filled syringe
PRD10950554 · Product
- Active substance
- Omalizumab
- Substance synonyms
- IGE-025A, SYN008
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 600 mg/l milligram(s)/litre
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03DX05 — OMALIZUMAB
- Marketing authorisation
- EU/1/05/319/024
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Mar Parc De Salut De Barcelona
- Sponsor organisation
- Consorci Mar Parc De Salut De Barcelona
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Pneumology
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Pneumology
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 110 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo_OPT-OMA-ASTHMA_v3_20220609 | 3 |
| Recruitment arrangements (for publication) | Reclutamiento_2021_12_26 | 1 |
| Subject information and informed consent form (for publication) | HIP-CI_omalizuamb_v3_20220609 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Spain | Acceptable with conditions 2025-01-30
|
2025-01-30 |