A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
NCT ID: NCT01728298
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
219 participants
INTERVENTIONAL
2012-11-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of SLITone in House Dust Mite Allergic Patients
NCT00633919
Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites
NCT02881879
Efficacy and Safety of Sublingual Immunotherapy (SLIT)
NCT01012882
Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma
NCT01930461
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
NCT01608243
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SLITone ULTRA low dose
SLITone ULTRA HDM immunotherapy
SLITone ULTRA HDM immunotherapy
SLITone ULTRA medium dose
SLITone ULTRA HDM immunotherapy
SLITone ULTRA HDM immunotherapy
SLITone ULTRA high dose
SLITone ULTRA HDM immunotherapy
SLITone ULTRA HDM immunotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SLITone ULTRA HDM immunotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ALK-Abelló A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alain Didier, Pr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Larrey, Toulouse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Proffesor Alain Didier
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SU-M-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.