Efficacy and Safety of Grass-SPIRE Registration Study

Rhinitis Clinical Trial

Official title:

A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02795273
• Other study ID #: TG005
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 5, 2016
• Last updated: June 21, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinitis

Intervention

Drug:
• Grass-SPIRE

• Placebo

Locations

Country	Name	City	State
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Circassia Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined Score of symptoms and allergy medication	Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication	Approximately 66 weeks	No
Primary	Safety of Grass-SPIRE	Measurement of adverse events	Approximately 66 weeks	Yes
Secondary	Symptom Scores	Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects	Approximately 66 weeks	No
Secondary	Rescue Medication Use	Use of allergy medication to help allergy symptoms	Approximately 66 weeks	No
Secondary	Quality of Life	Assessment of Quality of Life measured by responses to a questionnaire	Approximately 66 weeks	No