Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis; Asthma
• Interventions: Biological: Ragweed-SPIRE; Biological: Placebo

• Registration Number: NCT02061670
• Lead Sponsor: Circassia Limited

Brief Summary

The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Male or female, aged 18-65 years.
• Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
• A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
• Positive skin prick test to ragweed
• Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.

Exclusion Criteria

• History of life-threatening asthma.
• Uncontrolled asthma according to GINA
• FEV1 of < 70 % of predicted, regardless of the cause.
• Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
• History of severe drug allergy or anaphylactic reaction to food.
• A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ragweed-SPIRE 1	Ragweed-SPIRE	Ragweed-SPIRE regimen 1 given 2 weeks apart
Ragweed-SPIRE 2	Ragweed-SPIRE	Ragweed-SPIRE regimen 2 given 2 weeks apart
Placebo	Placebo	Placebo given 2 weeks apart

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks

Secondary Outcome Measures

Name	Time	Method
Number of subjects with asthma exacerbations as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks
Evaluation of change in lung function as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks

Trial Locations

Locations (5)

Inflamax Research; 🇨🇦 Toronto, Ontario, Canada

Cheema Research Inc; 🇨🇦 Mississauga, Ontario, Canada

Kanata Allergy Services; 🇨🇦 Kanata, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Ottawa Allergy Research Corp; 🇨🇦 Ottawa, Ontario, Canada