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

NCT02061670 | Completed Phase 2

• 1 other identifier: TR007
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

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.

Conditions

Seasonal Allergic Rhinitis; Asthma

Keywords

Ragweed; Allergy; rhinoconjunctivitis; rhinitis; asthma

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events as a measure of safety and tolerability

  Throughout subjects participation in the study, approximately 22 weeks

Secondary Outcomes (2)

• Number of subjects with asthma exacerbations as a measure of safety and tolerability

  Throughout subjects participation in the study, approximately 22 weeks

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

  Throughout subjects participation in the study, approximately 22 weeks

Study Arms (3)

Ragweed-SPIRE 1

EXPERIMENTAL

Ragweed-SPIRE regimen 1 given 2 weeks apart

Biological: Ragweed-SPIRE

Ragweed-SPIRE 2

EXPERIMENTAL

Ragweed-SPIRE regimen 2 given 2 weeks apart

Biological: Ragweed-SPIRE

Placebo

PLACEBO COMPARATOR

Placebo given 2 weeks apart

Biological: Placebo

Interventions

Ragweed-SPIRE BIOLOGICAL

Intradermal injection

Ragweed-SPIRE 1; Ragweed-SPIRE 2

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (5)

Kanata Allergy Services

Kanata, Ontario, K2L 3C8, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Cheema Research Inc

Mississauga, Ontario, L5A 3V, Canada

Location

Ottawa Allergy Research Corp

Ottawa, Ontario, K1Y 4G2, Canada

Location

Inflamax Research

Toronto, Ontario, L4W 1A4, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Asthma; Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 13, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

CA (5)