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

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ClinicalTrials.gov Identifier: NCT02061670
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : January 21, 2015
Sponsor:
Collaborator:
Adiga Life Sciences, Inc.
Information provided by (Responsible Party):
Circassia Limited

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Asthma Biological: Ragweed-SPIRE Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Ragweed-SPIRE 1
Ragweed-SPIRE regimen 1 given 2 weeks apart
Biological: Ragweed-SPIRE
Intradermal injection

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Number of subjects with asthma exacerbations as a measure of safety and tolerability [ Time Frame: Throughout subjects participation in the study, approximately 22 weeks ]
  2. Evaluation of change in lung function as a measure of safety and tolerability [ Time Frame: Throughout subjects participation in the study, approximately 22 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061670


Locations
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Canada, Ontario
Kanata Allergy Services
Kanata, Ontario, Canada, K2L 3C8
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Cheema Research Inc
Mississauga, Ontario, Canada, L5A 3V
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada, K1Y 4G2
Inflamax Research
Toronto, Ontario, Canada, L4W 1A4
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.

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Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02061670     History of Changes
Other Study ID Numbers: TR007
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Circassia Limited:
Ragweed
Allergy
rhinoconjunctivitis
rhinitis
asthma

Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases