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Efficacy Study Of Ragweed Sublingual-Oral Immunotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Greer Laboratories
ClinicalTrials.gov Identifier:
NCT01353079
First received: May 11, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergy
 Biological: allergy immunotherapy
Biological: placebo and short ragweed allergenic extract
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Greer Laboratories:

Primary Outcome Measures:
  • combined daily rhinoconjunctivitis symptom and medication scores [ Time Frame: 2011 Ragweed pollen season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • daily rhinoconjunctivitis symptom and medication scores [ Time Frame: 3 peak weeks of the short ragweed pollen season ] [ Designated as safety issue: No ]

Enrollment: 429
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ragweed allergenic Extract Biological: allergy immunotherapy
Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.
Biological: placebo and short ragweed allergenic extract
Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
Placebo Comparator: Glycero-Cocas Biological: placebo and short ragweed allergenic extract
Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353079

Locations
United States, Virginia
Site 7
Warrenton, Virginia, United States, 20186
Sponsors and Collaborators
Greer Laboratories
  More Information

No publications provided

Responsible Party: Greer Laboratories
ClinicalTrials.gov Identifier: NCT01353079     History of Changes
Other Study ID Numbers: SLIT10-01
Study First Received: May 11, 2011
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013