A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
Phase 2
Completed
- Conditions
- Allergic Rhinitis
- Registration Number
- NCT01728298
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
Inclusion Criteria
- Aged 18 or older
- Moderate to severe persistent HDM allergic rhinitis with or without asthma
- Moderate to severe HDM allergic rhinitis symptoms during a baseline period
- Positive skin prick test response (wheal diameter ≥ 3 mm)
- Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)
Exclusion Criteria
- Previous treatment with immunotherapy with House dust mite immunotherapy
- Ongoing treatment with any allergen specific immunotherapy product
- Reduced lung function
- Clinical history of uncontrolled asthma
- Inflammatory conditions in the oral cavity with severe symptoms
- History of anaphylaxis with cardiorespiratory symptoms
- History of recurrent generalised urticaria
- A history of drug induced facial angioedema or hereditary angiooedema
- Any clinically relevant chronic disease (≥3 months duration)
- Systemic disease affecting the immune system
- Immunosuppressive treatment
- Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in IgE-blocking factor after 6 months of treatment 6 months
- Secondary Outcome Measures
Name Time Method Number of subjects with treatment related adverse events 6 months
Trial Locations
- Locations (1)
Proffesor Alain Didier
🇫🇷Toulouse, France
Proffesor Alain Didier🇫🇷Toulouse, France