An Exploratory Study of PQ Grass 27600 SU

Rhinitis, Allergic, Seasonal Clinical Trial

Official title: A Randomised, Double-blind, Placebo-controlled Exploratory Study to Explore the Efficacy and Safety of PQ Grass 27600 SU in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Exposure

Status Completed

Clinical Trial Summary

PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure.

Clinical Trial Description

PQGrass309 is a randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure. The study is expected to be conducted in the United States (US) and the European Union (EU). The study will enrol enough subjects to allow treatment of approximately 150 subjects.

The aim of this exploratory field study is to explore amongst others the following:

• The efficacy and safety (up to 6 months following treatment) of a cumulative dose of 27600 standardised units (SU) of PQ Grass in the treatment of grass pollen allergy.

• The expected average treatment effect on combined symptom and medication score. ;

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

• NCT number: NCT04687059
• Study type: Interventional
• Source: Allergy Therapeutics
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 19, 2020
• Completion date: October 28, 2021