Status:
COMPLETED
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
Detailed Description
The objective of this study is to determine the biologic activity of a Glycyphagus domesticus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference prep...
Eligibility Criteria
Inclusion
- Subject inclusion criteria:
- A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Glycyphagus domesticus.
- Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.
- Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
- Age ≥ 18 years and ≤ 50 years
- Subject can be male or female
- Subject must be capable of providing written informed consent
- Subject exclusion criteria:
- Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
- Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
- Use of drugs that may interfere with the skin reactions.
- Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
- Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
- Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00917488
Start Date
May 1 2009
End Date
July 1 2010
Last Update
June 20 2011
Active Locations (1)
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1
Clinica Dr. Lobatón
Cadiz, Cadiz, Spain, 11008