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Safety and Tolerability Study of Ragweed SLIT Tablets

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT01224834
First received: October 13, 2010
Last updated: November 5, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Rhinitis, Allergic, Seasonal
Ragweed Pollen Allergy
 Drug: Sublingual tablet of ragweed pollen allergen extract
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunological markers (IgE and IgG4) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224834

Locations
Hungary
DRC Drug Research Center
Balatonfüred, Hungary, H-8230
Sponsors and Collaborators
Stallergenes
Quintiles
Investigators
Principal Investigator: Eva Péterfai, MD DRC Drug Research Center, Balatonfüred - Hungary
  More Information

No publications provided

Responsible Party: Olivier de Beaumont/Medical Director, Stallergenes SA
ClinicalTrials.gov Identifier: NCT01224834     History of Changes
Other Study ID Numbers: VO63.08 HUN
Study First Received: October 13, 2010
Last Updated: November 5, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Stallergenes:
Ragweed, allergy, sublingual immunotherapy

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

ClinicalTrials.gov processed this record on May 16, 2013