A MULTICENTER, PHASE II, RANDOMISED, DOUBLE?BLIND, PLACEBO CONTROLED CLINICAL TRIAL OF THE SUBCUTANEOUS IMMUNOTHERAPY IN DIFFERENT DOSES WITH PARALLEL GROUPS IN SUBJECTS WITH ALLERGIC RHINOCONJUNCTIVITIS +/- ASTHMA SENSITIZED TO DERMATOPHAGOIDES PTERONYSSINUS.
Phase 1
- Conditions
- Allergic rhinoconjunctivitis with or without associated asthma.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-004583-30-ES
- Lead Sponsor
- BIAL Industrial Farmaceutica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Compare the efficacy of subcutaneous immunotherapy in depot presentation in five different doses in sensitive patients to Dermatophagoides pteronyssinus with asthma +/- allergic rhinoconjunctivitis, between 18 and 60 years old.;Secondary Objective: Not applicable;Primary end point(s):
- Secondary Outcome Measures
Name Time Method