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Completed

NCT Number: NCT01728298

A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

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.

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Key information

Conditions

Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Proffesor Alain Didier

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLITone ULTRA HDM immunotherapy

Biological

Primary outcomes

  1. Change from baseline in IgE-blocking factor after 6 months of treatment

    Time frame: 6 months

Secondary outcomes

  1. Number of subjects with treatment related adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial

Acronym: SUMMIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 19, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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