Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma

Phase 2

Completed

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

• Registration Number: NCT02161107
• Lead Sponsor: Circassia Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 grass for at least the previous two grass seasons.
• Positive skin prick test to grass.
• Grass-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).
• 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, 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
Grass-SPIRE 2	Grass-SPIRE	Grass-SPIRE regimen 2 given 2 weeks apart
Grass-SPIRE 1	Grass-SPIRE	Grass-SPIRE regimen 1 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 15 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 15 weeks
Evaluation of change in lung function as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 15 weeks

Trial Locations

Locations (5)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Inflamax Research; 🇨🇦 Mississauga, Ontario, Canada

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

Centre de Recherche Appliquée en Allergie de Québec; 🇨🇦 Quebec, Canada

Cheema Research Inc; 🇨🇦 Mississauga, Ontario, Canada