Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

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®.
Positive skin prick test to Perennial Rye grass or Timothy grass allergen
...
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®.
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.

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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
...
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.

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

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®.
Positive skin prick test to Perennial Rye grass or Timothy grass allergen
...
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®.
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.

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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
...
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.

Tracking Information

NCT #
NCT02075138
Collaborators
  • Syneos Health
  • CIDAL
Investigators
Not Provided