Seasonal Allergic Rhinitis Clinical Trial
Official title:
A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis
Verified date | October 2009 |
Source | Stallergenes |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Office for Safety in Health Care |
Study type | Interventional |
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
Status | Completed |
Enrollment | 89 |
Est. completion date | August 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Male or female outpatients 18-50 years old - grass pollen rhinoconjunctivitis of at least 2 years. - positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening. - written consent - a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge) Exclusion Criteria: - Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study - Asthma requiring treatment other than short-acting beta-2 inhaled agonists. - Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Allergy Center Vienna West, Vienna Challenge Chamber - | Vienna |
Lead Sponsor | Collaborator |
---|---|
Stallergenes |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rhinoconjunctivitis Total Symptom Score (RTSS) of the 6 rhinoconjunctivitis symptoms in response to grass pollen challenge in the active group compared to placebo, | four months | No | |
Secondary | Rhinoconjunctivitis Total symptom score (RTSS) in response to grass pollen challenge in the active group compared to placebo | one week, one, and two months | No | |
Secondary | Onset of action of treatment | one week, one, two and four months | No | |
Secondary | Skin Prick Tests | one, two and four months | No | |
Secondary | Safety of treatment | The duration of treatment period | Yes |
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