- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06027073
Biologics and Sublingual Immunotherapy (BSIPL)
Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Andrzej Bozek, prof
- Phone Number: 0048608318547
- Email: andrzejbozek@o2.pl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:• >18 years old
- 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
Exclusion Criteria:
- 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
- Contraindicating allergen immunotherapy and omalizumab treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
|
|
Active Comparator: omalizumab
standard antiasthmatic therapy and omalizumab
|
adding omalizumab to anti asthmatic therapy
|
Active Comparator: oral tablet HDM-immunotherapy
standard antiasthmatic therapy and oral immunotherapy
|
adding omalizumab to anti asthmatic therapy
|
Active Comparator: combi therapy
standard antiasthmatic therapy and omalizumab, and oral immunotherapy
|
adding omalizumab to anti asthmatic therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Time Frame: 3 years
|
Daily dose of inhaled steroids (changes)
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM-01966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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