Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619827
• Other study ID #: VO56.07 A
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2008
• Last updated: October 8, 2009
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2009
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Biological:
• Sublingual immunotherapy tablets of grass pollen allergen extract
300IR allergen-based tablets once daily during four months

Locations

Country	Name	City	State
Austria	Allergy Center Vienna West, Vienna Challenge Chamber -	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinoconjunctivitis Total Symptom Score (RTSS) of the 6 rhinoconjunctivitis symptoms in response to grass pollen challenge in the active group compared to placebo,		four months	No
Secondary	Rhinoconjunctivitis Total symptom score (RTSS) in response to grass pollen challenge in the active group compared to placebo		one week, one, and two months	No
Secondary	Onset of action of treatment		one week, one, two and four months	No
Secondary	Skin Prick Tests		one, two and four months	No
Secondary	Safety of treatment		The duration of treatment period	Yes