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Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00367640
First received: August 22, 2006
Last updated: October 8, 2009
Last verified: October 2009
History of Changes
  Purpose

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage


Condition Intervention Phase
Allergy
 Biological: Sublingual immunotherapy tablets - grass pollen
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • • To assess the efficacy of SLIT on the Rhinoconjunctivitis Total Symptom Score (RTSS)

Secondary Outcome Measures:
  • Rescue medication usage.
  • 6individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS).
  • Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score.
  • Global evaluation by the patient.
  • To document the safety of the treatment

Estimated Enrollment: 600
Study Start Date: November 2004
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Written consent
  • Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
  • Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
  • Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
  • Safety laboratory resuts within the references ranges
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367640

Sponsors and Collaborators
Stallergenes
Investigators
Principal Investigator: Alain DIDIER, Professor Hôpital Rangueil-Larrey, Toulouse, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00367640     History of Changes
Other Study ID Numbers: VO34.04
Study First Received: August 22, 2006
Last Updated: October 8, 2009
Health Authority: Austria: Federal Ministry for Social Security and Generations
Bulgaria: Ministry of Health, Executive Drug Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco
Slovakia: State Institute for Drug Control
Spain: Agencia Espanola del Medicamento y Productos Sanitaros

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013