Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
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®.
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

Exclusion Criteria

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.
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.
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

Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
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®.
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

Exclusion Criteria

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.
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.
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