Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00619827
First received: February 8, 2008
Last updated: April 18, 2016
Last verified: April 2016
  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
Drug: 300 IR grass pollen allergen extract tablet
Drug: Placebo tablet
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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 89
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 300 IR
300 IR grass pollen allergen extract tablet
Drug: 300 IR grass pollen allergen extract tablet
300 IR grass pollen allergen extract tablet once daily during four months
Other Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo tablet
Placebo tablet once daily during four months
Other Name: Sublingual placebo tablet

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, VIENNA, AUSTRIA
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00619827     History of Changes
Other Study ID Numbers: VO56.07 A 
Study First Received: February 8, 2008
Results First Received: January 25, 2016
Last Updated: April 18, 2016
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Stallergenes:
Sublingual immunotherapy
Rhinitis
Conjunctivitis
Allergen challenge
Allergen exposition chamber
Grass pollen tablet
Allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2016