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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ragweed-SPIRE 1

Ragweed-SPIRE regimen 1 given 2 weeks apart

Group Type EXPERIMENTAL

Ragweed-SPIRE

Intervention Type BIOLOGICAL

Intradermal injection

Ragweed-SPIRE 2

Ragweed-SPIRE regimen 2 given 2 weeks apart

Group Type EXPERIMENTAL

Ragweed-SPIRE

Intervention Type BIOLOGICAL

Intradermal injection

Placebo

Placebo given 2 weeks apart

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Ragweed-SPIRE

Intradermal injection

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No