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

Study Overview
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Brief Summary
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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

Official Title
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A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Grass-SPIRE in Subjects With Asthma and Grass-Induced Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinitis, Asthma

Intervention / Treatment
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* Biological: Grass-SPIRE
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grass-SPIRE 1<br>Grass-SPIRE regimen 1 given 2 weeks apart | Biological: Grass-SPIRE<br>* Intradermal injection<br>|
| Experimental: Grass-SPIRE 2<br>Grass-SPIRE regimen 2 given 2 weeks apart | Biological: Grass-SPIRE<br>* Intradermal injection<br>|
| Placebo Comparator: Placebo<br>Placebo given 2 weeks apart | Biological: Placebo<br>* Intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grass, Allergy, rhinoconjunctivitis, rhinitis, asthma