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

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ClinicalTrials.gov Identifier: NCT00418379
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Allergy Drug: 300 IR (4M) Drug: 300 IR (2M) Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Primary Completion Date : August 2010
Study Completion Date : September 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Average Adjusted Symptom Score (AAdSS) [ Time Frame: Pollen period (average of 33.8 days) of Year 3 ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418379


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