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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: April 18, 2016
Last verified: April 2016
  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: 300 IR (4M)
Drug: 300 IR (2M)
Drug: Placebo
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:
  • Average Adjusted Symptom Score (AAdSS) [ Time Frame: Pollen period (average of 33.8 days) of Year 3 ] [ Designated as safety issue: No ]

    The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.

    Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.



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 (4M)
300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
Drug: 300 IR (4M)
300 IR grass pollen allergen extract tablet starting 4 months before the pollen season
Other Name: Sublingual immunotherapy tablet
Experimental: 300 IR (2M)
300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
Drug: 300 IR (2M)
300 IR grass pollen allergen extract tablet starting 2 months before the pollen season
Other Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo
Placebo tablet
Other Name: Sublingual placebo tablet

  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 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

Publications:
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00418379     History of Changes
Other Study ID Numbers: VO53.06 
Study First Received: January 3, 2007
Results First Received: January 25, 2016
Last Updated: April 18, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Austria: Federal Ministry for Health Family and Youth

Keywords provided by Stallergenes:
Sublingual immunotherapy
Grass pollen tablet
Allergic rhinoconjunctivitis

ClinicalTrials.gov processed this record on September 28, 2016