Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

Allergy Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418379
• Other study ID #: VO53.06
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2007
• Last updated: June 4, 2012
• Start date: December 2006
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Austria: Federal Ministry for Social Security and GenerationsCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlCanada: Health CanadaRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: September 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male or female outpatients aged 18 to 50 years

• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons

• Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens

• A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria:

• Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.

• Asthma requiring treatment other than beta-2 inhaled agonists.

• Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Sublingual Immunotherapy tablets of grass pollen allergen extract
300 IR sublingual tablets starting 4 months before the pollen season 300 IR sublingual tablets starting 2 months before the pollen season Placebo.

Locations

Country	Name	City	State
France	DIDIER	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use	• To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: - The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use	Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy)	No
Secondary	- The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.		Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy)	No
Secondary	The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid).		Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy)	No
Secondary	To document the safety of the treatment		Years 1 to 5	Yes
Secondary	The Average Combined Score (ACS): A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS).		Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy)	No
Secondary	Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS).		Year 1, Year 2, Year 3 (sustained clinical efficacy), Year 4, Year 5 (post treatment long term efficacy)	No