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A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy (SUMMIT)

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ClinicalTrials.gov Identifier: NCT01728298
Recruitment Status : Completed
First Posted : November 19, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Biological: SLITone ULTRA HDM immunotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
Study Start Date : November 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SLITone ULTRA low dose
SLITone ULTRA HDM immunotherapy
 Biological: SLITone ULTRA HDM immunotherapy
Active Comparator: SLITone ULTRA medium dose
SLITone ULTRA HDM immunotherapy
 Biological: SLITone ULTRA HDM immunotherapy
Active Comparator: SLITone ULTRA high dose
SLITone ULTRA HDM immunotherapy
 Biological: SLITone ULTRA HDM immunotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in IgE-blocking factor after 6 months of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of subjects with treatment related adverse events [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728298


Locations
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France
Proffesor Alain Didier
Toulouse, France, 31059
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
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Principal Investigator: Alain Didier, Pr. Hôpital Larrey, Toulouse
More Information
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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01728298    
Other Study ID Numbers: SU-M-01
First Posted: November 19, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by ALK-Abelló A/S:
House Dust Mite
allergy
rhinitis
asthma
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases