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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Adiga Life Sciences
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT02061670
First received: February 3, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Asthma
Biological: Ragweed-SPIRE
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Throughout subjects participation in the study, approximately 22 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of subjects with asthma exacerbations as a measure of safety and tolerability [ Time Frame: Throughout subjects participation in the study, approximately 22 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of change in lung function as a measure of safety and tolerability [ Time Frame: Throughout subjects participation in the study, approximately 22 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061670

Locations
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
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02061670     History of Changes
Other Study ID Numbers: TR007
Study First Received: February 3, 2014
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Ragweed
Allergy
rhinoconjunctivitis
rhinitis
asthma

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

ClinicalTrials.gov processed this record on August 25, 2014