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Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619827
First Posted: February 21, 2008
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stallergenes Greer
February 8, 2008
February 21, 2008
January 25, 2016
May 23, 2016
May 23, 2016
September 2007
March 2008   (Final data collection date for primary outcome measure)
Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours [ Time Frame: 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.
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 ]
Complete list of historical versions of study NCT00619827 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
  • Onset of action of treatment [ Time Frame: one week, one, two and four months ]
  • Skin Prick Tests [ Time Frame: one, two and four months ]
  • Safety of treatment [ Time Frame: The duration of treatment period ]
Not Provided
Not Provided
 
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • 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
  • Drug: Placebo tablet
    Placebo tablet once daily during four months
    Other Name: Sublingual placebo tablet
  • Experimental: 300 IR
    300 IR grass pollen allergen extract tablet
    Intervention: Drug: 300 IR grass pollen allergen extract tablet
  • Placebo Comparator: Placebo
    Placebo tablet
    Intervention: Drug: Placebo tablet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00619827
VO56.07 A
No
Not Provided
Not Provided
Stallergenes Greer
Stallergenes Greer
Not Provided
Principal Investigator: Friedrich HORAK, Pr. MD Allergy Center Vienna West, VIENNA, AUSTRIA
Stallergenes Greer
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP