Clinical trial NCT02061709: Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
Official title: A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinoconjunctivitis
Rhinitis
Seasonal
Ragweed
Allergy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2014-02-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
timeFrame: Between Baseline and approximately 25 weeks after randomisation
Secondary outcomes:
measure: Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints
timeFrame: Between Baseline and approximately 25 weeks after randomisation
measure: Change from Baseline in mean Total Nasal Symptom Score (TNSS)
timeFrame: Aproximately 25 weeks after randomisation
measure: Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)
timeFrame: Approximately 25 weeks after randomisation
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: Approximately 28 weeks
Other outcomes:
Locations:
city: Kanata
country: Canada
facility: Kanata Allergy Services
state: Ontario
city: London
country: Canada
facility: KGK Synergize Inc
state: Ontario
city: Mississauga
country: Canada
facility: Inflamax Research
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Allergy Asthma Associates
state: Ontario
Study officials:
affiliation: Inflamax Research
name: Piyush Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: