- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161107
Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma
March 23, 2015 updated by: Circassia Limited
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Quebec, Canada
- Centre De Recherche Appliquée en Allergie De Québec
-
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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Mississauga, Ontario, Canada, L8P 0A1
- Inflamax Research
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Mississauga, Ontario, Canada, L5A 3V
- Cheema Research Inc
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Ottawa, Ontario, Canada, K1Y 4G2
- Ottawa Allergy Research Corp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo given 2 weeks apart
|
Intradermal injection
|
Experimental: Grass-SPIRE 1
Grass-SPIRE regimen 1 given 2 weeks apart
|
Intradermal injection
|
Experimental: Grass-SPIRE 2
Grass-SPIRE regimen 2 given 2 weeks apart
|
Intradermal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame: Throughout subjects participation in the study, approximately 15 weeks
|
Throughout subjects participation in the study, approximately 15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with asthma exacerbations as a measure of safety and tolerability
Time Frame: Throughout subjects participation in the study, approximately 15 weeks
|
Throughout subjects participation in the study, approximately 15 weeks
|
Evaluation of change in lung function as a measure of safety and tolerability
Time Frame: Throughout subjects participation in the study, approximately 15 weeks
|
Throughout subjects participation in the study, approximately 15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
June 10, 2014
First Submitted That Met QC Criteria
June 10, 2014
First Posted (Estimate)
June 11, 2014
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
Other Study ID Numbers
- TG004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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