Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Registration Number
- NCT02061709
- Lead Sponsor
- Circassia Limited
- Brief Summary
The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
- Male or female, aged 18-65 years.
- Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
- Minimum qualifying rhinoconjunctivitis symptom scores
- Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.
Exclusion Criteria
- Subjects with a history of ragweed pollen induced asthma
- A history of anaphylaxis to ragweed allergen.
- FEV1 < 80 % of predicted.
- Subjects who cannot tolerate Baseline Challenge in the EEC.
- Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
- A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) Between Baseline and approximately 25 weeks after randomisation
- Secondary Outcome Measures
Name Time Method Change from Baseline in mean Total Nasal Symptom Score (TNSS) Aproximately 25 weeks after randomisation Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints Between Baseline and approximately 25 weeks after randomisation Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS) Approximately 25 weeks after randomisation Number of Participants with Adverse Events as a Measure of Safety and tolerability Approximately 28 weeks
Trial Locations
- Locations (5)
Kanata Allergy Services
🇨🇦Kanata, Ontario, Canada
KGK Synergize Inc
🇨🇦London, Ontario, Canada
Inflamax Research
🇨🇦Mississauga, Ontario, Canada
Taunton Health Centre
🇨🇦Oshawa, Ontario, Canada
Windsor Allergy Asthma Associates
🇨🇦Windsor, Ontario, Canada
Kanata Allergy Services🇨🇦Kanata, Ontario, Canada