Safety and Tolerability Study of Ragweed SLIT Tablets

Rhinitis, Allergic, Seasonal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224834
• Other study ID #: VO63.08 HUN
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2010
• Last updated: November 5, 2010
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2010
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ragweed Pollen Allergy
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days

Locations

Country	Name	City	State
Hungary	DRC Drug Research Center	Balatonfüred

Sponsors (2)

Lead Sponsor	Collaborator
Stallergenes	Quintiles, Inc.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks		2 weeks	No
Secondary	Immunological markers (IgE and IgG4)		2 weeks	No