NCT00367640

Brief Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Trial Health

100
On Track

Trial Health Score

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

Enrollment
628

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

May 23, 2016

Completed
Last Updated

May 23, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

August 22, 2006

Results QC Date

January 25, 2016

Last Update Submit

April 18, 2016

Conditions

Allergy

Keywords

Sublingual immunotherapyGrass pollen tabletAllergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Average Rhinoconjunctivitis Total Symptom Score

    Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 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). The lower the score, the better the outcome.

    Pollen period (average of 32 days in the ITT set)

Study Arms (4)

100 IR

EXPERIMENTAL

100 IR grass pollen allergen extract tablet

Drug: 100 IR grass pollen allergen extract tablet

300 IR

EXPERIMENTAL

300 IR grass pollen allergen extract tablet

Drug: 300 IR grass pollen allergen extract tablet

500 IR

EXPERIMENTAL

500 IR grass pollen allergen extract tablet

Drug: 500 IR grass pollen allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

100 IR grass pollen allergen extract tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Also known as: Sublingual immunotherapy tablet
100 IR
300 IR grass pollen allergen extract tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Also known as: Sublingual immunotherapy tablet
300 IR
500 IR grass pollen allergen extract tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Also known as: Sublingual immunotherapy tablet
500 IR
Placebo tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Also known as: Sublingual placebo tablet
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written consent
  • Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
  • Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
  • Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
  • Safety laboratory resuts within the references ranges

You may not qualify if:

  • Pregnancy, breast-feeding/lactation
  • Had received desensitisation treatment for grass pollen
  • Treatment by immunotherapy with another allergen within the previous 5 years
  • Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
  • Treated with beta-blockers or under continuous corticotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.

    PMID: 17935764RESULT

MeSH Terms

Conditions

Hypersensitivity

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

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

  • Alain DIDIER, Professor

    Hôpital Rangueil-Larrey, Toulouse, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
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

August 22, 2006

First Posted

August 23, 2006

Study Start

November 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

May 23, 2016

Results First Posted

May 23, 2016

Record last verified: 2016-04