NCT00803244

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2016

Completed
Last Updated

May 25, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

November 27, 2008

Results QC Date

January 25, 2016

Last Update Submit

April 18, 2016

Conditions

Primary Disease

Keywords

allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pollen period (average of 32.1 days)

Study Arms (2)

300 IR

EXPERIMENTAL

300 IR grass pollen allergen extract tablet

Drug: 300 IR

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

300 IRDRUG

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

Also known as: Sublingual immunotherapy tablet
300 IR
PlaceboDRUG

Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Also known as: Sublingual placebo tablet
Placebo

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stallergenes Sa

Antony, 92183, France

Location

Hop Montauban

Montauban, France

Location

Cab medical

Orange, France

Location

Azienda Ospedaliera

Parma, Italy

Location

Complejo Hospitalario de Caceres

Cáceres, Spain

Location

HGU La Paz

Madrid, Spain

Location

MeSH Terms

Interventions

Sublingual Immunotherapy

Intervention Hierarchy (Ancestors)

Desensitization, ImmunologicImmunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Results Point of Contact

Title
Laurence Paolozzi, Medical Director
Organization
Stallergenes
lpaolozzi@stallergenes.com
+33 (0) 1 55 59 26 33

Study Officials

  • DE BLAY Frédéric, MD

    NHC, Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 5, 2008

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

January 1, 2010

Last Updated

May 25, 2016

Results First Posted

May 25, 2016

Record last verified: 2016-04

Locations

FR(3)IT(1)ES(2)