Clinical trial NCT02297490: Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
Official title: Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Healthy Volunteers
Keywords: Environmental Exposure Chamber
Specific Immunotherapy
SIT
SCIT
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Inflamax Research Incorporated
First posted: 2014-11-21
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Symptom Score (TSS)
timeFrame: 1 year
measure: Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
timeFrame: Grass pollen season from March until July (approx. 11 weeks avarage)
measure: Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
timeFrame: Grass pollen season from March until July (approx. 11 weeks avarage)
Secondary outcomes:
measure: Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects
timeFrame: 1 year
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Inflamax Research INC
state: Ontario
Study officials:
name: Piyush Patel, Dr.
role: PRINCIPAL_INVESTIGATOR
References: