Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies

NCT00599872 | Completed Phase 3 Results

• 1 other identifier: SLIT07-01
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 30

Brief Summary

The purpose of this study is to determine an effective dose range for the administration of ragweed allergenic extract via the sublingual route of administration

Conditions

Allergic Rhinitis

Keywords

Allergy; Sublingual Immunotherapy; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season

  Symptom score defined as sum of scores from eight 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). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.

  Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months

Secondary Outcomes (5)

• Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)

  09/01/2008-09/07/2008

• Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)

  Ragweed pollen season 08/01/08 to 10/30/08

• Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);

  Ragweed pollen season 08/01/08 to 10/30/08

• Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject

  Ragweed pollen season 08/01/08 to 10/30/08

• Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)

  Ragweed pollen season 08/01/08 to 10/30/08

Study Arms (2)

Ragweed Allergenic Extract

ACTIVE COMPARATOR

Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)

Biological: Standardized Ragweed Allergenic Extract

Placebo

PLACEBO COMPARATOR

Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route

Biological: Placebo

Interventions

Standardized Ragweed Allergenic Extract BIOLOGICAL

Standardized Ragweed Allergenic Extract, sublingual oral

Ragweed Allergenic Extract

Placebo BIOLOGICAL

Placebo, sublingual oral

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult ragweed-sensitive Subjects with allergic rhinoconjunctivitis with or without asthma during ragweed pollen season.
• Subjects must be 18 to 50 years of age.
• Test Subjects will have a history of moderate to severe isolated or unseasonal allergic rhinoconjunctivitis with or without mild intermittent asthma symptoms attributable to ragweed pollen for a minimum of 2 years before study entry.
• Subjects with or with out a history of asthma will possess FEV1 and PEF greater than or equal to 80% predicted at the beginning of the study established by spirometry and defined by the Knudson predicted set.
• Sensitivity to the relevant allergen will be documented by a positive skin prick test result performed along with negative (saline) and positive (histamine) control skin tests. A positive test will be defined as the skin reaction having the longest wheal diameter of 5mm or greater or the longest erythema diameter of 10 mm or greater at 15-20 minutes after application.
• All female Subjects of child-bearing potential will be required to provide a urine sample for pregnancy testing that must be negative before being allowed to participate in the study.

You may not qualify if:

• Subjects must be trained on the proper use of the EpiPen, and sign the EpiPenTraining Form before being allowed to enroll in the study.
• Subjects must be mentally and physically capable of self-administering oral drug.
• Subjects having a history of anaphylaxis or history consistent with persistent asthma
• Subjects taking antihistamines or nasal steroids medications greater than twice a week in the months of January and/or February.
• Subjects with chronic sinusitis unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the test drug or pose additional risk to the Subject.
• Subjects having perennial or structurally related rhinitis or rhinitis medicamentosa (from excessive use of nasal decongestants) that will interfere with the evaluation of symptoms due to ragweed allergy.
• Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication.
• Subjects who have received an experimental drug in the 30 days prior to admission into this study or who plan to use an experimental drug during the study.
• Subjects who have received Anti-IgE medications (Xolair) or similar compounds in the last 12 months.
• Subjects who have received ragweed allergen immunotherapy in the last 3 years prior to admission into this study.
• Subjects who are current users of inhaled, oral, intramuscular, intravenous corticosteroids, tricyclic antidepressants, beta blockers, or MAO inhibitors.
• Subjects using beta-agonist more than twice a month unless being taken prior to exercise.
• Subjects using medications that could induce adverse gastrointestinal reactions during the study. Subjects using such medications must prove stable with no side effects for at least 3 months prior to enrollment.
• Subjects refusing to sign the EpiPen Training Form will be excluded from the study.
• Pregnant or breast feeding females.

Sponsors & Collaborators

• Greer Laboratories: lead

Study Sites (30)

Sneeze, Wheeze, & Itch Associates

Normal, Illinois, 61761, United States

Location

Welborn Clinic

Evansville, Indiana, 47713, United States

Location

Iowa Clinical Research Corporation

Iowa City, Iowa, 52240, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66210, United States

Location

Kansas City Allergy and Asthma

Overland Park, Kansas, 66210, United States

Location

Family Allergy and Asthma Respiratory Institute

Louisville, Kentucky, 40215, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research of the Ozarks

Rolla, Missouri, 64501, United States

Location

Midwest Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Asthma, Immunology and Allergy Association, LLC

Lincoln, Nebraska, 68505, United States

Location

Midwest Allergy and Asthma Clinic, PA

Omaha, Nebraska, 68130, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

Ocean Allergy and Respiratory Research Center

Brick, New Jersey, 08724, United States

Location

Pulmonary and Allergy Associates, PA

Summit, New Jersey, 07901, United States

Location

Allergy and Respiratory Center

Canton, Ohio, 44718, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Oklahoma Allergy & Asthma Clinic, PC

Oklahoma City, Oklahoma, 73104, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Allergy and Asthma Specialists, PC

Blue Bell, Pennsylvania, 19422, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

Vanderbilt ASAP Research

Nashville, Tennessee, 08724, United States

Location

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, 75231, United States

Location

Allergy, Asthma and Sinus Center, SC

Greenfield, Wisconsin, 53228, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Aurora Advanced Healthcare, Inc

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: Bob Esch, VP Research & Development
• Organization: Greer Laboratories

esch@greerlabs.com

828.759.7845

Study Officials

• Robert E. Esch, PhD

  Greer Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 24, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 14, 2015
• Results First Posted: January 14, 2015

Record last verified: 2014-12

Locations

US (30)