Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

• ClinicalTrials.gov Identifier: NCT00803244
• Recruitment Status: Completed
• First Posted: December 5, 2008
• Results First Posted: May 25, 2016
• Last Update Posted: May 25, 2016
• Sponsor: Stallergenes Greer
• Information provided by (Responsible Party): Stallergenes Greer

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Condition or disease	Intervention/treatment	Phase
Primary Disease	Drug: 300 IR; Drug: Placebo	Phase 3

Detailed Description:

To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:

- The Average Adjusted Symptom Score (AASS).

To document the safety of the treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
• Study Start Date: January 2009
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 300 IR; 300 IR grass pollen allergen extract tablet	Drug: 300 IR; 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season; Other Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo; Placebo tablet	Drug: Placebo; Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season; Other Name: Sublingual placebo tablet

Outcome Measures

Primary Outcome Measures :

1. Average Adjusted Symptom Score (AAdSS) [ Time Frame: Pollen period (average of 32.1 days) ]

   The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.

   Participants assessed daily, during the 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

1. Male or female outpatients aged 12 to 65 years (inclusive).
2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
3. Positive SPT
4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion Criteria:

1. Positive SPT to any other seasonal allergens present during the grass pollen season
2. Patients with clinically significant confounding symptoms of allergy to other allergens
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).

Contacts and Locations

Locations

France

Stallergenes Sa

Antony, France, 92183

Hop Montauban

Montauban, France

Cab medical

Orange, France

Italy

Azienda Ospedaliera

Parma, Italy

Spain

Complejo Hospitalario de Caceres

Caceres, Spain

HGU La Paz

Madrid, Spain

Sponsors and Collaborators

Stallergenes Greer

Investigators

• Principal Investigator: DE BLAY Frédéric, MD; NHC, Hôpitaux Universitaires de Strasbourg

More Information

• Responsible Party: Stallergenes Greer
• ClinicalTrials.gov Identifier: NCT00803244
• Other Study ID Numbers: VO60.08
• First Posted: December 5, 2008
• Results First Posted: May 25, 2016
• Last Update Posted: May 25, 2016
• Last Verified: April 2016

Keywords provided by Stallergenes Greer:

allergic rhinoconjunctivitis

Additional relevant MeSH terms:

Conjunctivitis; Conjunctival Diseases; Eye Diseases