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

NCT00418379 | Completed Phase 3 Results DMC

• 1 other identifier: VO53.06
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Allergy

Keywords

Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Average Adjusted Symptom Score (AAdSS)

  The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.

  Pollen period (average of 33.8 days) of Year 3

Study Arms (3)

300 IR (4M)

EXPERIMENTAL

300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

Drug: 300 IR (4M)

300 IR (2M)

EXPERIMENTAL

300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

Drug: 300 IR (2M)

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

300 IR (4M) DRUG

300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

Also known as: Sublingual immunotherapy tablet

300 IR (4M)

300 IR (2M) DRUG

300 IR grass pollen allergen extract tablet starting 2 months before the pollen season

Also known as: Sublingual immunotherapy tablet

300 IR (2M)

Placebo DRUG

Placebo tablet

Also known as: Sublingual placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (1)

DIDIER

Toulouse, 31400, France

Location

Related Publications (3)

• Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, Melac M, Malling HJ. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011 Sep;128(3):559-66. doi: 10.1016/j.jaci.2011.06.022. Epub 2011 Jul 29.

  PMID: 21802126 RESULT

• Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, Soulie S, Zeldin RK. Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy. 2013 May;43(5):568-77. doi: 10.1111/cea.12100.

  PMID: 23600548 RESULT

• Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015 May 22;5:12. doi: 10.1186/s13601-015-0057-8. eCollection 2015.

  PMID: 26097680 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Laurence Paolozzi, Medical Director
• Organization: Stallergenes

lpaolozzi@stallergenes.com

+33 (0) 1 55 59 26 33

Study Officials

• Alain DIDIER, MD, Pr

  Hôpital Rangueil-Larrey, Toulouse, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 25, 2016
• Results First Posted: May 25, 2016

Record last verified: 2016-04

Locations

FR (1)