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Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409409
First Posted: December 8, 2006
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stallergenes Greer
  Purpose
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.

Condition Intervention Phase
Allergy Drug: 300 IR grass pollen allergen extract tablet Drug: Placebo tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis

Further study details as provided by Stallergenes Greer:

Primary Outcome Measures:
  • Average Rhinoconjunctivitis Total Symptom Score (ARTSS) [ Time Frame: Pollen period (average of 38.6 days) ]

    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.



Enrollment: 278
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 300 IR
300 IR grass pollen allergen extract tablet
Drug: 300 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Other Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Other Name: Sublingual placebo tablet

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who have received any desensitisation treatment for grass pollen.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409409


Locations
Germany
Charité - Campus Virchow Klinikum
Berlin, Germany
Sponsors and Collaborators
Stallergenes Greer
Investigators
Principal Investigator: Ulrich Wahn, Professor Charité - Campus Virchow Klinikum, Berlin, Germany
  More Information

Publications:
Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT00409409     History of Changes
Other Study ID Numbers: VO52.06
First Submitted: December 7, 2006
First Posted: December 8, 2006
Results First Submitted: January 25, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016
Last Verified: April 2016

Keywords provided by Stallergenes Greer:
Sublingual immunotherapy
Grass pollen tablet
Allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases