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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367640
First Posted: August 23, 2006
Last Update Posted: May 23, 2016
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.
Information provided by (Responsible Party):
Stallergenes Greer
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Greer:

Primary Outcome Measures:
  • Average Rhinoconjunctivitis Total Symptom Score [ Time Frame: Pollen period (average of 32 days in the ITT set) ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00367640


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

Publications:
Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT00367640     History of Changes
Other Study ID Numbers: VO34.04
First Submitted: August 22, 2006
First Posted: August 23, 2006
Results First Submitted: January 25, 2016
Results First Posted: May 23, 2016
Last Update Posted: May 23, 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