Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract - Full Text View

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Biological: Sublingual immunotherapy tablets of grass pollen allergen extract	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Further study details as provided by Stallergenes:

Primary Outcome Measures:

Rhinoconjunctivitis Total Symptom Score (RTSS) of the 6 rhinoconjunctivitis symptoms in response to grass pollen challenge in the active group compared to placebo, [ Time Frame: four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rhinoconjunctivitis Total symptom score (RTSS) in response to grass pollen challenge in the active group compared to placebo [ Time Frame: one week, one, and two months ] [ Designated as safety issue: No ]
Onset of action of treatment [ Time Frame: one week, one, two and four months ] [ Designated as safety issue: No ]
Skin Prick Tests [ Time Frame: one, two and four months ] [ Designated as safety issue: No ]
Safety of treatment [ Time Frame: The duration of treatment period ] [ Designated as safety issue: Yes ]

Enrollment:	89
Study Start Date:	September 2007
Study Completion Date:	August 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Biological: Sublingual immunotherapy tablets of grass pollen allergen extract 300IR allergen-based tablets once daily during four months
Experimental: 2 Sublingual tablet of grass pollen allergen extract in dose of 300 IR once daily	Biological: Sublingual immunotherapy tablets of grass pollen allergen extract 300IR allergen-based tablets once daily during four months

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619827

Locations

Austria
Allergy Center Vienna West, Vienna Challenge Chamber -
Vienna, Austria, 1150

Sponsors and Collaborators

Stallergenes

Investigators

Principal Investigator:

Friedrich HORAK, Pr. MD

Allergy Center Vienna West, VIENNE, AUSTRIA

More Information

No publications provided by Stallergenes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bonvalet M, Moussu H, Wambre E, Ricarte C, Horiot S, Rimaniol AC, Kwok WW, Horak F, de Beaumont O, Baron-Bodo V, Moingeon P. Allergen-specific CD4+ T cell responses in peripheral blood do not predict the early onset of clinical efficacy during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2012 Dec;42(12):1745-55. doi: 10.1111/cea.12015.

Responsible Party:	Olivier de Beaumont, Medical Director, Stallergènes S.A.
ClinicalTrials.gov Identifier:	NCT00619827 History of Changes
Other Study ID Numbers:	VO56.07 A
Study First Received:	February 8, 2008
Last Updated:	October 8, 2009
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by Stallergenes:

Allergy
Rhinitis
Conjuntivitis
Allergen challenge

Allergen exposition chamber
ALLERGY
HYPERSENSITIVITY

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity

Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 21, 2013