Grass Observational Study
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 100
Inclusion Criteria
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- ...
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
Exclusion Criteria
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- ...
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
Summary
- Conditions
- Grass Allergy
- Rhinoconjunctivitis
- Type
- Observational
- Design
- Time Perspective: Prospective
Participation Requirements
- Age
- Between 12 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- ...
- Positive skin prick test to Perennial Rye grass or Timothy grass allergen
- History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
Exclusion Criteria
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- ...
- Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
Tracking Information
- NCT #
- NCT02075138
- Collaborators
- Syneos Health
- CIDAL
- Investigators
- Not Provided
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