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Completed

NCT Number: NCT02161107

Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma

The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to subjects suffering from both grass allergy and asthma

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston General Hospital, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, aged 18-65 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 grass for at least the previous two grass seasons.
  • Positive skin prick test to grass.
  • Grass-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).
  • 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, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Treatment and study plan

Grass-SPIRE

Biological

Intradermal injection

Placebo

Biological

Intradermal injection

Primary outcomes

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

    Time frame: Throughout subjects participation in the study, approximately 15 weeks

Secondary outcomes

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

    Time frame: Throughout subjects participation in the study, approximately 15 weeks

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

    Time frame: Throughout subjects participation in the study, approximately 15 weeks

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Official study title

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Grass-SPIRE in Subjects With Asthma and Grass-Induced Rhinoconjunctivitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2014
Registry last updated
Mar 24, 2015

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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