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®.
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
Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.
...
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.

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®.
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
Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.
...
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.
Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
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.

Locations

Medford, Oregon
Spokane, Washington
Sylvania, Ohio
Washington, District of Columbia
Normal, Illinois
...
Medford, Oregon
Spokane, Washington
Sylvania, Ohio
Washington, District of Columbia
Normal, Illinois
Temuco, Araucanía
Buenos Aires City, Buenos Aires

Tracking Information

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