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Completed

NCT Number: NCT02075138

Grass Observational Study

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.

The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires City, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • CIDAL
  • Syneos Health

Registry information

Official study title

An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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