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

Healthy Volunteers Clinical Trial

Official title:

Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02297490
• Other study ID #: AL1304AV
• Secondary ID: AL13BP01
• Status: Terminated
• Phase: Phase 2
• First received: November 12, 2014
• Last updated: January 16, 2018
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Allergopharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic
• Healthy Volunteers

Intervention

Drug:
• 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.

Biological:
• 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.

Locations

Country	Name	City	State
Canada	Inflamax Research INC	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Allergopharma GmbH & Co. KG	Inflamax Research Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Symptom Score (TSS)	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 treatment	1 year
Primary	Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)	The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)	Grass pollen season from March until July (approx. 11 weeks avarage)
Primary	Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)	The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)	Grass pollen season from March until July (approx. 11 weeks avarage)
Secondary	Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects	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.	1 year