Back to results

Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

Primary Purpose

Seasonal Allergic Rhinitis, Asthma

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Ragweed-SPIRE

Placebo

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Ragweed, 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 ragweed for at least the previous two ragweed seasons.
Positive skin prick test to ragweed
Ragweed-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 or severe hypertension).
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, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Sites / Locations

Kanata Allergy Services
Kingston General Hospital
Cheema Research Inc
Ottawa Allergy Research Corp
Inflamax Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ragweed-SPIRE 1

Ragweed-SPIRE 2

Placebo

Arm Description

Ragweed-SPIRE regimen 1 given 2 weeks apart

Ragweed-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

NCT ID

NCT02061670

First Posted

February 3, 2014

Last Updated

January 20, 2015

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02061670

Brief Title

Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (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

5. Study Description

Brief Summary

The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed 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

Ragweed, 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

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ragweed-SPIRE 1

Arm Type

Experimental

Arm Description

Ragweed-SPIRE regimen 1 given 2 weeks apart

Arm Title

Ragweed-SPIRE 2

Arm Type

Experimental

Arm Description

Ragweed-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)

Ragweed-SPIRE

Intervention Description

Intradermal injection

Intervention Type

Biological

Intervention Name(s)

Placebo

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 22 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 22 weeks

Title

Evaluation of change in lung function as a measure of safety and tolerability

Time Frame

Throughout subjects participation in the study, approximately 22 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 ragweed for at least the previous two ragweed seasons. Positive skin prick test to ragweed Ragweed-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 or severe hypertension). 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, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Facility Information:

Facility Name

Kanata Allergy Services

City

Kanata

State/Province

Ontario

ZIP/Postal Code

K2L 3C8

Country

Canada

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

Ottawa Allergy Research Corp

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4G2

Country

Canada

Facility Name

Inflamax Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

L4W 1A4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

We'll reach out to this number within 24 hrs