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Completed

NCT Number: NCT00418379

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

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

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DIDIER

Toulouse, 31400, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300 IR (4M)

Drug

300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

Other names: Sublingual immunotherapy tablet

300 IR (2M)

Drug

300 IR grass pollen allergen extract tablet starting 2 months before the pollen season

Other names: Sublingual immunotherapy tablet

Placebo

Drug

Placebo tablet

Other names: Sublingual placebo tablet

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jan 4, 2007
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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