Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy And Safety Trial Of Sublingual-Oral Immunotherapy (SLIT) In Adults With Allergic Rhinoconjunctivitis Caused By Ragweed Pollen
1 other identifier
interventional
429
1 country
1
Brief Summary
The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.
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 Apr 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
February 5, 2015
CompletedFebruary 5, 2015
January 1, 2015
7 months
May 11, 2011
September 8, 2014
January 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]
Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.
2011 ragweed pollen season, 8/2011 -10/2011
Secondary Outcomes (3)
Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)
3 peak weeks of the 2011 ragweed pollen season
Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)
2011 ragweed pollen season; 8/2011 - 10/2011
Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)
3 peak weeks of the 2011 ragweed pollen season
Study Arms (2)
Short Ragweed Pollen Allergenic Extract
EXPERIMENTALGlycero-COCAs
PLACEBO COMPARATORInterventions
Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Eligibility Criteria
You may qualify if:
- allergic to ragweed
You may not qualify if:
- not allergic to ragweed
- history of anaphylaxis
- subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
- Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
- Subjects who have received experimental drug within 30 days prior to study admission
- Subjects who have received anit-IgE medications in the last 12 months
- Subjects who have received ragweed immunotherapy in the last 3 years
- Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
- Subjects refusing to sign epi-pen training form
- Females who are pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site 7
Warrenton, Virginia, 20186, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Terrance Coyne, M.D., Executive Vice President of Research & Development; Chief Medical Officer
- Organization
- GREER Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
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
May 11, 2011
First Posted
May 12, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2011
Study Completion
April 1, 2012
Last Updated
February 5, 2015
Results First Posted
February 5, 2015
Record last verified: 2015-01