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

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Biological: Short Ragweed Pollen Allergenic Extract; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Warrenton, Virginia, United States, 20186
      • Site 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• allergic to ragweed

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Ragweed Pollen Allergenic Extract	Biological: Short Ragweed Pollen Allergenic Extract; 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.
Placebo Comparator: Glycero-COCAs	Biological: Placebo; Placebo: Glycero-COCAs sublingual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)	Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. 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. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.	3 peak weeks of the 2011 ragweed pollen season
Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)	Change in baseline in avg daily RSS 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 Total Score Range: 0 (min) - 48 (max); lower score was more favorable. 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.	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)	Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS). 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 Total Score Range: 0 (min) - 48 (max); lower score was more favorable. 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 three peak weeks of ragweed pollen season.	3 peak weeks of the 2011 ragweed pollen season

Collaborators and Investigators

• Sponsor: Greer Laboratories

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: January 22, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SLIT10-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No