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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00367640
First received: August 22, 2006
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Condition Intervention Phase
Allergy
Drug: 100 IR grass pollen allergen extract tablet
Drug: 300 IR grass pollen allergen extract tablet
Drug: 500 IR grass pollen allergen extract tablet
Drug: Placebo tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:
  • Average Rhinoconjunctivitis Total Symptom Score [ Time Frame: Pollen period (average of 32 days in the ITT set) ] [ Designated as safety issue: No ]

    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: 628
Study Start Date: November 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 IR
100 IR grass pollen allergen extract tablet
Drug: 100 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
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
Experimental: 500 IR
500 IR grass pollen allergen extract tablet
Drug: 500 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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Pregnancy, breast-feeding/lactation
  • Had received desensitisation treatment for grass pollen
  • Treatment by immunotherapy with another allergen within the previous 5 years
  • Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
  • Treated with beta-blockers or under continuous corticotherapy
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00367640     History of Changes
Other Study ID Numbers: VO34.04 
Study First Received: August 22, 2006
Results First Received: January 25, 2016
Last Updated: April 18, 2016
Health Authority: Austria: Federal Ministry for Social Security and Generations
Bulgaria: Ministry of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2016