Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
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
1 other identifier
interventional
473
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedResults Posted
Study results publicly available
May 19, 2016
CompletedMay 19, 2016
April 1, 2016
10 months
August 3, 2009
January 25, 2016
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Pollen period (average of 42.8 days)
Study Arms (2)
300 IR
EXPERIMENTAL300 IR grass pollen allergen extract tablet
Placebo
PLACEBO COMPARATORPacebo tablet
Interventions
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
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Sneeze, wheeze, and Itch Associates, LLC
Normal, Illinois, 61761, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40508, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Respiratory Medical Research Institute of Michigan PLC
Ypsilanti, Michigan, 48197, United States
Clinical Research of the Ozarks, Inc.
Columbia, Missouri, 65203, United States
Midwest Clinical Research LLC
St Louis, Missouri, 63141, United States
Clinical Research of the Ozarks, Inc
Warrensburg, Missouri, 64093, United States
Montana Allergy & Asthma Specialists
Billings, Montana, 59101, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Creighton University - Allergy & Asthma
Omaha, Nebraska, 68131, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231, United States
Allergy and Asthma Research Group
Eugene, Oregon, 97401, United States
Baker Allergy, Asthma, & Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, 97504, United States
Allergy Associates Research
Portland, Oregon, 97213, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
North West Asthma Allergy Center
Vancouver, Washington, 98664, United States
Related Publications (1)
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.
PMID: 23122534RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laurence Paolozzi, Medical Director
- Organization
- Stallergenes
Study Officials
- PRINCIPAL INVESTIGATOR
COX Linda, MD
Allergists and Immunologists - Fort Lauderdale - Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 10, 2009
Study Start
October 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
May 19, 2016
Results First Posted
May 19, 2016
Record last verified: 2016-04