Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Phase 1

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: 300 IR grass pollen allergen extract tablet; Drug: Placebo tablet

• Registration Number: NCT00619827
• Lead Sponsor: Stallergenes Greer

Brief Summary

The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Detailed Description

The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-21
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2016-01-25
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Results First Posted: 2016-05-23
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Male or female outpatients 18-50 years old
• grass pollen rhinoconjunctivitis of at least 2 years.
• positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
• written consent
• a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)

Exclusion Criteria

• Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
• Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
• Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 IR	300 IR grass pollen allergen extract tablet	300 IR grass pollen allergen extract tablet
Placebo	Placebo tablet	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours	4 months	The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.

Trial Locations

Locations (1)

Allergy Center Vienna West, Vienna Challenge Chamber -; 🇦🇹 Vienna, Austria