NCT00409409

Brief Summary

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

May 26, 2016

Completed
Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

December 7, 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 (ARTSS)

    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 38.6 days)

Study Arms (2)

300 IR

EXPERIMENTAL

300 IR grass pollen allergen extract tablet

Drug: 300 IR grass pollen allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

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
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

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female outpatients aged 5 to 17 years.
  • Written consent / assent.
  • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
  • Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
  • Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

You may not qualify if:

  • Patients who have received any desensitisation treatment for grass pollen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Campus Virchow Klinikum

Berlin, Germany

Location

Related Publications (1)

  • Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.

    PMID: 19046761RESULT

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

  • Ulrich Wahn, Professor

    Charité - Campus Virchow Klinikum, Berlin, Germany

    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

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 26, 2016

Results First Posted

May 26, 2016

Record last verified: 2016-04

Locations

DE(1)