Efficacy and Safety of Grass-SPIRE Registration Study

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Rhinitis, Conjunctivitis

In brief

The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

Key facts

Study ID

NCT02795273

Run by

Circassia Limited

People needed

0

Starts

2016-05-01

Last updated by the study team

2016-06-23

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
• Score of ≤ 21 on RCAT questionnaire
• Rye grass specific IgE of ≥ 0.7 kU/L
• Positive skin prick test to Rye grass whole allergen extract

You may not qualify if…

• History or findings of significant disease
• Asthma requiring GINA Step 3 or higher treatment
• History of severe drug allergy, severe angioedema or systemic allergic reaction
• Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
• Contraindications for administration of epinephrine

Where it is running

• Study site — Canton, Ohio, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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