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Completed

NCT Number: NCT02478060

Birch-SPIRE Safety and Efficacy Study

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.

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Key information

Conditions

Rhinitis Hypersensitivity Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de Recherche Appliqué en Allergie de Québec

Québec, Quebec, G1V 4M6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Birch-SPIRE

Biological

Placebo

Biological

Primary outcomes

  1. Safety of Birch-SPIRE administrations measured by Adverse Events

    Time frame: Up to 16 weeks after start of dosing

Secondary outcomes

  1. Measurement of IgE as a Pharmacodynamic parameter

    Time frame: Up to 9 months after start of dosing

  2. Conjunctival Provocation Test as a Pharmacodynamic parameter

    Time frame: Up to 9 months after start of dosing

  3. Skin Prick Testing as a Pharmacodynamic parameter

    Time frame: Up to 9 months after start of dosing

Other outcomes

  1. Allergy symptoms and allergy medication use during next Birch season

    Time frame: Up to 9 months after start of dosing

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Quintiles, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
First posted
Jun 23, 2015
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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