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: August 21, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 21, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014