Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
- Conditions
- Allergic RhinoconjunctivitisHealthy Volunteers
- Interventions
- Drug: PlaceboBiological: Allergovit 6-grasses
- Registration Number
- NCT02297490
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 158
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Allergovit 6-grasses immunotherapy 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.
- Primary Outcome Measures
Name Time Method Total Symptom Score (TSS) 1 year Analysis of the relationship between different methods of measurement of efficacy of SIT.
The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatmentRhinoconjunctivitis Symptom and Medication Score (RC-SMS) Grass pollen season from March until July (approx. 11 weeks avarage) The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)
Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) Grass pollen season from March until July (approx. 11 weeks avarage) The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)
- Secondary Outcome Measures
Name Time Method Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects 1 year Evaluation of the relationship of symptoms experienced in EEC and natural grass pollen season. Assessment of symptom specificity provoked by EEC in non-allergic subjects.
Trial Locations
- Locations (1)
Inflamax Research INC
🇨🇦Mississauga, Ontario, Canada