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

January 20, 2015 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

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

  • Canada
    • Ontario
      • Kanata, Ontario, Canada, K2L 3C8
        • Kanata Allergy Services
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Mississauga, Ontario, Canada, L5A 3V
        • Cheema Research Inc
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Ottawa Allergy Research Corp
      • Toronto, Ontario, Canada, L4W 1A4
        • Inflamax Research

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 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)

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
Experimental: Ragweed-SPIRE 2
Ragweed-SPIRE regimen 2 given 2 weeks apart
Biological: Ragweed-SPIRE
Intradermal injection
Placebo Comparator: Placebo
Placebo given 2 weeks apart
Biological: Placebo
Experimental: Ragweed-SPIRE 1
Ragweed-SPIRE regimen 1 given 2 weeks apart
Biological: Ragweed-SPIRE
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 22 weeks
Throughout subjects participation in the study, approximately 22 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 22 weeks
Throughout subjects participation in the study, approximately 22 weeks
Evaluation of change in lung function as a measure of safety and tolerability
Time Frame: Throughout subjects participation in the study, approximately 22 weeks
Throughout subjects participation in the study, approximately 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR007

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.

Clinical Trials on Asthma

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe