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

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma; Seasonal Allergic Rhinitis

Treatments: Biological: Placebo; Biological: Ragweed-SPIRE

Study type: Interventional

Funder types: Industry

Identifiers

NCT02061670

TR007

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 3 patient groups, including a placebo group

Ragweed-SPIRE 1

Experimental group

Description:

Ragweed-SPIRE regimen 1 given 2 weeks apart

Treatment:

Biological: Ragweed-SPIRE

Ragweed-SPIRE 2

Experimental group

Description:

Ragweed-SPIRE regimen 2 given 2 weeks apart

Treatment:

Biological: Ragweed-SPIRE

Placebo

Placebo Comparator group

Description:

Placebo given 2 weeks apart

Treatment:

Biological: Placebo