Efficacy and Safety of Grass-SPIRE Registration Study
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Grass-SPIRE Eight intradermal injections of Grass-SPIRE |
Drug: Grass-SPIRE
|
Placebo Comparator: Placebo Eight intradermal injections of Placebo |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Combined Score of symptoms and allergy medication [Approximately 66 weeks]
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
- Safety of Grass-SPIRE [Approximately 66 weeks]
Measurement of adverse events
Secondary Outcome Measures
- Symptom Scores [Approximately 66 weeks]
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
- Rescue Medication Use [Approximately 66 weeks]
Use of allergy medication to help allergy symptoms
- Quality of Life [Approximately 66 weeks]
Assessment of Quality of Life measured by responses to a questionnaire
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Canton | Ohio | United States | ||
2 | Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | United States | 45231 |
Sponsors and Collaborators
- Circassia Limited
Investigators
- Principal Investigator: David Bernstein, MD, University of Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TG005