Safety and Tolerability Study of Ragweed SLIT Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224834
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : November 8, 2010
Quintiles, Inc.
Information provided by:
Stallergenes Greer

Brief Summary:
The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Ragweed Pollen Allergy Drug: Sublingual tablet of ragweed pollen allergen extract Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Bee pollen
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
Experimental: 2 Drug: Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days

Primary Outcome Measures :
  1. Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Immunological markers (IgE and IgG4) [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • written consent
  • male or female subjects from 18 yo 60 years old and in general good health
  • for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
  • symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
  • sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
  • FEV1 at least of 80% of predicted value at screening

Exclusion Criteria:

  • past or current disease which, as judged by the investigator, may affect the outcome of this study
  • history of life-threatening asthma
  • asthma requiring daily treatment (whatever the pharmaceutical class)
  • pregnant or lactating women
  • subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
  • symptoms during the treatment phase due to a sensitivity to a second allergen
  • subjects treated with ongoing immunotherapy with another allergen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01224834

DRC Drug Research Center
Balatonfüred, Hungary, H-8230
Sponsors and Collaborators
Stallergenes Greer
Quintiles, Inc.
Principal Investigator: Eva Péterfai, MD DRC Drug Research Center, Balatonfüred - Hungary

Responsible Party: Olivier de Beaumont/Medical Director, Stallergenes SA Identifier: NCT01224834     History of Changes
Other Study ID Numbers: VO63.08 HUN
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: October 2010

Keywords provided by Stallergenes Greer:
Ragweed, allergy, sublingual immunotherapy

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate