- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728298
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy (SUMMIT)
January 20, 2014 updated by: ALK-Abelló A/S
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
219
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toulouse, France, 31059
- Proffesor Alain Didier
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Active Comparator: SLITone ULTRA low dose
SLITone ULTRA HDM immunotherapy
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Active Comparator: SLITone ULTRA medium dose
SLITone ULTRA HDM immunotherapy
|
|
Active Comparator: SLITone ULTRA high dose
SLITone ULTRA HDM immunotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in IgE-blocking factor after 6 months of treatment
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with treatment related adverse events
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alain Didier, Pr., Hôpital Larrey, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
November 2, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimate)
November 19, 2012
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-M-01
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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