EUCTR2010-023176-12-BE
Active, not recruiting
Phase 1
Clinical efficacy, immunogenicity, clinical tolerability and assessment of safety of gpASIT+TM administered orally, according to two administration schedules, for the prophylaxis of seasonal grass pollen rhinoconjunctivitis - Not available
Biotech Tools sa0 sites414 target enrollmentOctober 21, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of seasonal grass pollen rhinoconjunctivitis
- Sponsor
- Biotech Tools sa
- Enrollment
- 414
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has given written informed consent
- •Age between 18 and 50 years
- •The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- •Male or non pregnant, non\-lactating female
- •Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •oA medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
- •oA positive skin prick test (wheal diameter \= 3 mm) to grass\-pollen mixture
- •oSpecific IgE against grass pollen (IgE \> 0\.7 kU/l)
- •oAsymptomatic to perennial inhalant allergens
Exclusion Criteria
- •Subjects with current immunotherapy and subjects who underwent an immunotherapy within the last 2 years
- •Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
- •A history of hypersensitivity to the excipients
- •Subjects with perennial asthma.
- •Subjects requiring control medication against asthma from step 2 according to GINA classification (ref. is made to Appendix 5\)
- •Subjects with an VC \< 80% and a FEV1 \< 70% of predicted value
- •Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
- •Subjects with rhinitis medicamentosa, non\-specific rhinitis (to food dye, preservative agent…)
- •Subjects symptomatic to perennial inhalant allergens
- •Subjects with a history of hepatic or renal disease
Outcomes
Primary Outcomes
Not specified
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