Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00418379
First received: January 3, 2007
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis


Condition Intervention Phase
Allergy
Drug: Sublingual Immunotherapy tablets of grass pollen allergen extract
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use [ Time Frame: Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy) ] [ Designated as safety issue: No ]

    • To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on:

    - The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use



Secondary Outcome Measures:
  • - The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. [ Time Frame: Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy) ] [ Designated as safety issue: No ]
  • The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid). [ Time Frame: Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy) ] [ Designated as safety issue: No ]
  • To document the safety of the treatment [ Time Frame: Years 1 to 5 ] [ Designated as safety issue: Yes ]
  • The Average Combined Score (ACS): A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS). [ Time Frame: Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy) ] [ Designated as safety issue: No ]
  • Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS). [ Time Frame: Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy) ] [ Designated as safety issue: No ]

Enrollment: 633
Study Start Date: December 2006
Study Completion Date: September 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 300 IR 4months (4M) before the pollen season
300 IR Grass pollen allergen extract- sublingual immunotherapy tablet - starting 4 months before the pollen season
Drug: Sublingual Immunotherapy tablets of grass pollen allergen extract
  • 300 IR sublingual tablets starting 4 months before the pollen season
  • 300 IR sublingual tablets starting 2 months before the pollen season
  • Placebo.
Experimental: 300 IR 2 months (2M) before the pollen season
300 IR Grass pollen allergen extract- sublingual immunotherapy tablet - starting 2 months before pollen season
Drug: Sublingual Immunotherapy tablets of grass pollen allergen extract
  • 300 IR sublingual tablets starting 4 months before the pollen season
  • 300 IR sublingual tablets starting 2 months before the pollen season
  • Placebo.
Placebo
Placebo
Drug: Sublingual Immunotherapy tablets of grass pollen allergen extract
  • 300 IR sublingual tablets starting 4 months before the pollen season
  • 300 IR sublingual tablets starting 2 months before the pollen season
  • Placebo.

  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 aged 18 to 50 years
  • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
  • Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
  • A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria:

  • Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
  • Asthma requiring treatment other than beta-2 inhaled agonists.
  • Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.
  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: NCT00418379

Locations
France
DIDIER
Toulouse, France, 31400
Sponsors and Collaborators
Stallergenes
Investigators
Principal Investigator: Alain DIDIER, MD, Pr Hôpital Rangueil-Larrey, Toulouse, France
  More Information

No publications provided by Stallergenes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00418379     History of Changes
Other Study ID Numbers: VO53.06
Study First Received: January 3, 2007
Last Updated: June 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Federal Ministry for Social Security and Generations
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation

ClinicalTrials.gov processed this record on July 29, 2014