A clinical trial in a controlled setting to learn more about allergies caused by house dust
- Conditions
- House Dust Induced Rhinitis/RhinoconjunctivitisMedDRA version: 14.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-001855-38-AT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?Subject is male or female and =18 years of age
?Subject has AR/ARC to house dust of >=1 year duration
?TNSS >= 6 of 12 during the screening EEC session.
?Positive skin prick test response to D. pteronyssinus and/or D. farinae (Allergopharma) at the Screening Visit (>=3mm wheal).
?Serum specific IgE to D. pteronyssinus and/or D. farinae >= Class 2.
?FEV1 >= 70% of predicted value at the Screening and Randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
?Subject is sensitized and regularly exposed seasonal allergens which could potentially interfere with EEC sessions.
?Previous immunotherapy with HDM for >=1 month within the 3 years of V3
?Ongoing treatment with immunotherapy
?Unstable or severe asthma; history of a life-threatening asthma attack or deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids within 3 months prior to Screening.
?Requirement for medium or high-dose ICS within 12 months of V1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method