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

Primary Purpose

Seasonal Allergic Rhinitis, Asthma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Grass-SPIRE
Placebo
Sponsored by
Circassia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Grass, Allergy, rhinoconjunctivitis, rhinitis, asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Kingston General Hospital
  • Cheema Research Inc
  • Inflamax Research
  • Ottawa Allergy Research Corp
  • Centre de Recherche Appliquée en Allergie de Québec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Grass-SPIRE 1

Grass-SPIRE 2

Placebo

Arm Description

Grass-SPIRE regimen 1 given 2 weeks apart

Grass-SPIRE regimen 2 given 2 weeks apart

Placebo given 2 weeks apart

Outcomes

Primary Outcome Measures

Number of subjects with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Number of subjects with asthma exacerbations as a measure of safety and tolerability
Evaluation of change in lung function as a measure of safety and tolerability

Full Information

First Posted
June 10, 2014
Last Updated
March 23, 2015
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02161107
Brief Title
Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Asthma
Keywords
Grass, Allergy, rhinoconjunctivitis, rhinitis, asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grass-SPIRE 1
Arm Type
Experimental
Arm Description
Grass-SPIRE regimen 1 given 2 weeks apart
Arm Title
Grass-SPIRE 2
Arm Type
Experimental
Arm Description
Grass-SPIRE regimen 2 given 2 weeks apart
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given 2 weeks apart
Intervention Type
Biological
Intervention Name(s)
Grass-SPIRE
Intervention Description
Intradermal injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intradermal injection
Primary Outcome Measure Information:
Title
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame
Throughout subjects participation in the study, approximately 15 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with asthma exacerbations as a measure of safety and tolerability
Time Frame
Throughout subjects participation in the study, approximately 15 weeks
Title
Evaluation of change in lung function as a measure of safety and tolerability
Time Frame
Throughout subjects participation in the study, approximately 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Cheema Research Inc
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V
Country
Canada
Facility Name
Inflamax Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L8P 0A1
Country
Canada
Facility Name
Ottawa Allergy Research Corp
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Centre de Recherche Appliquée en Allergie de Québec
City
Quebec
Country
Canada

12. IPD Sharing Statement

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

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