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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02161107

Enrollment

Registered

2014-06-11

Start date

2014-04-30

Completion date

2015-03-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Seasonal Allergic Rhinitis

Keywords

Grass, Allergy, rhinoconjunctivitis, rhinitis, asthma

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

Interventions

BIOLOGICALGrass-SPIRE

Intradermal injection

BIOLOGICALPlacebo

Intradermal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026