Biologics and Sublingual Immunotherapy
ConditionAsthma, Allergic
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of Silesia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A total IgE between 30-700 IU/mL
Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
FEV1 >70% at baseline;
Positive skin prick test results for D. pteronyssinus, D. farinae
Disqualifiers
Sensitisation to other allergens with clinical signs not related to HDM
Uncontrolled asthma,
Other serious diseases or chronic unstable diseases
Allergen immunotherapy during the past 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
omalizumab
Biological/Vaccineadding omalizumab to anti asthmatic therapy
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: omalizumabActive comparator 1 intervention
Group B: oral tablet HDM-immunotherapyActive comparator 1 intervention
Group C: combi therapyActive comparator 1 intervention
Group D: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Daily dose of inhaled steroids (changes)
Time frame
3 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Silesia
Lead sponsor
Centrum Medyczne Andrzej Bożek
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: