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| Name | Class |
|---|---|
| Centrum Medyczne Andrzej Bożek | UNKNOWN |
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Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.
Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM.
Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omalizumab | Active Comparator | standard antiasthmatic therapy and omalizumab |
|
| oral tablet HDM-immunotherapy | Active Comparator | standard antiasthmatic therapy and oral immunotherapy |
|
| combi therapy | Active Comparator | standard antiasthmatic therapy and omalizumab, and oral immunotherapy |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Biological | adding omalizumab to anti asthmatic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effectiveness of combined therapy : omalizumab+ immunotherapy | Daily dose of inhaled steroids (changes) | 3 years |
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Inclusion Criteria:• >18 years old
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrzej Bozek, prof | Contact | 0048608318547 | andrzejbozek@o2.pl |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39363801 | Derived | Batard T, Taille C, Guilleminault L, Bozek A, Floch VB, Pfaar O, Canonica WG, Akdis C, Shamji MH, Mascarell L. Allergen Immunotherapy for the Prevention and Treatment of Asthma. Clin Exp Allergy. 2025 Feb;55(2):111-141. doi: 10.1111/cea.14575. Epub 2024 Oct 4. |
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by computer database registration
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows:
Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |