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

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergy
Interventions: Drug: 300 IR grass pollen allergen extract tablet
Drug: Placebo tablet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
300 IR 300 IR grass pollen allergen extract tablet
Placebo Placebo tablet

Participant Flow:   Overall Study
    300 IR   Placebo
STARTED   139   139 
COMPLETED   131   135 
Adverse Event                7                2 
Withdrawal by Subject                1                1 
Any other reason not above-mentioned                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) during the pollen period while on treatment.

Reporting Groups
300 IR 300 IR grass pollen allergen extract tablet
Placebo Placebo tablet
Total Total of all reporting groups

Baseline Measures
   300 IR   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   135   266 
[Units: Years]
Mean (Standard Deviation)
 10.5  (3.34)   11.2  (3.07)   10.9  (3.22) 
[Units: Participants]
Female   45   50   95 
Male   86   85   171 

  Outcome Measures

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Laurence Paolozzi, Medical Director
Organization: Stallergenes
phone: +33 (0) 1 55 59 26 33

Publications of Results:

Responsible Party: Stallergenes Greer 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