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

NCT02161107 | Completed Phase 2

• 1 other identifier: TG004
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

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

Conditions

Seasonal Allergic Rhinitis; Asthma

Keywords

Grass; Allergy; rhinoconjunctivitis; rhinitis; asthma

Outcome Measures

Primary Outcomes (1)

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

  Throughout subjects participation in the study, approximately 15 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

Grass-SPIRE 1

EXPERIMENTAL

Grass-SPIRE regimen 1 given 2 weeks apart

Biological: Grass-SPIRE

Grass-SPIRE 2

EXPERIMENTAL

Grass-SPIRE regimen 2 given 2 weeks apart

Biological: Grass-SPIRE

Placebo

PLACEBO COMPARATOR

Placebo given 2 weeks apart

Biological: Placebo

Interventions

Grass-SPIRE BIOLOGICAL

Intradermal injection

Grass-SPIRE 1; Grass-SPIRE 2

Placebo BIOLOGICAL

Intradermal injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (5)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Cheema Research Inc

Mississauga, Ontario, L5A 3V, Canada

Location

Inflamax Research

Mississauga, Ontario, L8P 0A1, Canada

Location

Ottawa Allergy Research Corp

Ottawa, Ontario, K1Y 4G2, Canada

Location

Centre de Recherche Appliquée en Allergie de Québec

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Asthma; Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 11, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CA (5)