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

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ClinicalTrials.gov Identifier: NCT00409409
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Stallergenes Greer

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.

Condition or disease Intervention/treatment Phase
Allergy Drug: 300 IR grass pollen allergen extract tablet Drug: Placebo tablet Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.




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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.

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

Publications of Results:
Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT00409409     History of Changes
Other Study ID Numbers: VO52.06
First Posted: December 8, 2006    Key Record Dates
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