Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).

There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.

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Detailed Description

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This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.

Conditions

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Allergic Rhinoconjunctivitis Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.

Allergovit 6-grasses immunotherapy

Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.

Group Type EXPERIMENTAL

Allergovit 6-grasses

Intervention Type BIOLOGICAL

Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.

Interventions

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Placebo

Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.

Intervention Type DRUG

Allergovit 6-grasses

Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.

Intervention Type BIOLOGICAL

Other Intervention Names

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Comparator Specific immunotherapy with an allergoid preparation.

Eligibility Criteria

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Inclusion Criteria

* IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
* positive skin prick test
* specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
* symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season

Exclusion Criteria

* undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
* currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
* allergens which are expected to interfere with the grass pollen season
* uncontrolled or partly controlled asthma
* patients with contraindications for SIT

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes