Birch-SPIRE Safety and Efficacy Study

Rhinitis Clinical Trial

Official title:

A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478060
• Other study ID #: CB001
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2015
• Last updated: November 7, 2016
• Start date: July 2015

Study information

• Verified date: November 2016
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18 to 65 years;

• Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen

• Birch IgE = 0.35 kU/L

• Positive skin prick test to whole birch allergen

Exclusion Criteria:

• Any past history of asthma

• FEV1 < 80% of predicted

• History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food

• Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm

• Administration of adrenaline (epinephrine) is contraindicated

• History of severe drug allergy or anaphylactic reaction to food.

• History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis

Intervention

Biological:
• Birch-SPIRE

• Placebo

Locations

Country	Name	City	State
Canada	Centre de Recherche Appliqué en Allergie de Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Quintiles, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Allergy symptoms and allergy medication use during next Birch season		Up to 9 months after start of dosing	No
Primary	Safety of Birch-SPIRE administrations measured by Adverse Events		Up to 16 weeks after start of dosing	Yes
Secondary	Measurement of IgE as a Pharmacodynamic parameter		Up to 9 months after start of dosing	No
Secondary	Conjunctival Provocation Test as a Pharmacodynamic parameter		Up to 9 months after start of dosing	No
Secondary	Skin Prick Testing as a Pharmacodynamic parameter		Up to 9 months after start of dosing	No