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Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Primary Purpose

Primary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
300 IR
Placebo
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Disease focused on measuring allergic rhinoconjunctivitis

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Male or female outpatients aged 12 to 65 years (inclusive).
  2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
  3. Positive SPT
  4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion Criteria:

  1. Positive SPT to any other seasonal allergens present during the grass pollen season
  2. Patients with clinically significant confounding symptoms of allergy to other allergens
  3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
  4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).

Sites / Locations

  • Stallergenes Sa
  • Hop Montauban
  • Cab medical
  • Azienda Ospedaliera
  • Complejo Hospitalario de Caceres
  • HGU La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

300 IR

Placebo

Arm Description

300 IR grass pollen allergen extract tablet

Placebo tablet

Outcomes

Primary Outcome Measures

Average Adjusted Symptom Score (AAdSS)
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the 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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2008
Last Updated
April 18, 2016
Sponsor
Stallergenes Greer
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1. Study Identification

Unique Protocol Identification Number
NCT00803244
Brief Title
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Official Title
A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stallergenes Greer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Detailed Description
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: - The Average Adjusted Symptom Score (AASS). To document the safety of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Disease
Keywords
allergic rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
300 IR
Arm Type
Experimental
Arm Description
300 IR grass pollen allergen extract tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
300 IR
Other Intervention Name(s)
Sublingual immunotherapy tablet
Intervention Description
300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sublingual placebo tablet
Intervention Description
Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season
Primary Outcome Measure Information:
Title
Average Adjusted Symptom Score (AAdSS)
Description
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the 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.
Time Frame
Pollen period (average of 32.1 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Male or female outpatients aged 12 to 65 years (inclusive). Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons. Positive SPT RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. Exclusion Criteria: Positive SPT to any other seasonal allergens present during the grass pollen season Patients with clinically significant confounding symptoms of allergy to other allergens Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed. Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DE BLAY Frédéric, MD
Organizational Affiliation
NHC, Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stallergenes Sa
City
Antony
ZIP/Postal Code
92183
Country
France
Facility Name
Hop Montauban
City
Montauban
Country
France
Facility Name
Cab medical
City
Orange
Country
France
Facility Name
Azienda Ospedaliera
City
Parma
Country
Italy
Facility Name
Complejo Hospitalario de Caceres
City
Caceres
Country
Spain
Facility Name
HGU La Paz
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

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