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Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

Primary Purpose

Allergic Rhinitis Due to Grass Pollens

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
300 IR
Placebo
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Grass Pollens focused on measuring allergic rhinoconjunctivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
  2. Positive SPT to grasses
  3. Total symptoms score for the previous pollen season more than 12 out of 18.
  4. Patients with FEV1 ≥ 80% of the predicted value.

Exclusion Criteria:

  1. Positive SPT to other grasses present during the grass pollen season and if endemic to the region
  2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
  3. Asthma requiring treatment with medications other than beta-2 inhaled agonists.
  4. Patients who have received any desensitization treatment for grass pollen in the past 5 years.
  5. Ongoing immunotherapy with any other allergen.
  6. Patients with any nasal or oral condition that could confound the efficacy or safety assessments
  7. Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
  8. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study.
  9. Patients treated with systemic or inhaled corticosteroids
  10. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
  11. Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above.
  12. Patients participating or having participated within 30 days before Screening in any clinical study.
  13. Patients who are unlikely to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which will compromise the data
  14. Patients with history of drug or alcohol abuse.
  15. Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study.
  16. Patients will not be randomized in this study more than once.

Sites / Locations

  • Sneeze, wheeze, and Itch Associates, LLC
  • University of Kentucky Medical Center
  • Allergy & Asthma Specialists, PSC
  • Johns Hopkins University
  • Respiratory Medical Research Institute of Michigan PLC
  • Clinical Research of the Ozarks, Inc.
  • Midwest Clinical Research LLC
  • Clinical Research of the Ozarks, Inc
  • Montana Allergy & Asthma Specialists
  • Montana Medical Research
  • Creighton University - Allergy & Asthma
  • Bernstein Clinical Research Center, LLC
  • Allergy and Asthma Research Group
  • Baker Allergy, Asthma, & Dermatology Research Center, LLC
  • Clinical Research Institute of Southern Oregon, P.C.
  • Allergy Associates Research
  • Allergy & Clinical Immunology Associates
  • Vanderbilt University Medical Center
  • North West Asthma Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

300 IR

Placebo

Arm Description

300 IR grass pollen allergen extract tablet

Pacebo tablet

Outcomes

Primary Outcome Measures

Combined Score (CS)
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2009
Last Updated
April 12, 2016
Sponsor
Stallergenes Greer
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1. Study Identification

Unique Protocol Identification Number
NCT00955825
Brief Title
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stallergenes Greer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Detailed Description
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population. Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes. Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications. In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season. Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Grass Pollens
Keywords
allergic rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
300 IR
Arm Type
Experimental
Arm Description
300 IR grass pollen allergen extract tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pacebo tablet
Intervention Type
Drug
Intervention Name(s)
300 IR
Other Intervention Name(s)
Sublingual immunotherapy tablet
Intervention Description
300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sublingual placebo tablet
Intervention Description
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Primary Outcome Measure Information:
Title
Combined Score (CS)
Description
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
Time Frame
Pollen period (average of 42.8 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. Positive SPT to grasses Total symptoms score for the previous pollen season more than 12 out of 18. Patients with FEV1 ≥ 80% of the predicted value. Exclusion Criteria: Positive SPT to other grasses present during the grass pollen season and if endemic to the region Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season Asthma requiring treatment with medications other than beta-2 inhaled agonists. Patients who have received any desensitization treatment for grass pollen in the past 5 years. Ongoing immunotherapy with any other allergen. Patients with any nasal or oral condition that could confound the efficacy or safety assessments Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance). Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. Patients treated with systemic or inhaled corticosteroids Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs. Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above. Patients participating or having participated within 30 days before Screening in any clinical study. Patients who are unlikely to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which will compromise the data Patients with history of drug or alcohol abuse. Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study. Patients will not be randomized in this study more than once.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
COX Linda, MD
Organizational Affiliation
Allergists and Immunologists - Fort Lauderdale - Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sneeze, wheeze, and Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Facility Name
Allergy & Asthma Specialists, PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Respiratory Medical Research Institute of Michigan PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Clinical Research of the Ozarks, Inc.
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Midwest Clinical Research LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research of the Ozarks, Inc
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Montana Allergy & Asthma Specialists
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Creighton University - Allergy & Asthma
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Allergy and Asthma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Baker Allergy, Asthma, & Dermatology Research Center, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, P.C.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Allergy & Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
North West Asthma Allergy Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23122534
Citation
Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, Melac M, Zeldin RK. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012 Dec;130(6):1327-34.e1. doi: 10.1016/j.jaci.2012.08.032. Epub 2012 Oct 31.
Results Reference
result

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Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

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