Back to results

Safety and Tolerability Study of Ragweed SLIT Tablets

Primary Purpose

Rhinitis, Allergic, Seasonal, Ragweed Pollen Allergy

Status

Completed

Phase

Phase 1

Locations

Hungary

Study Type

Interventional

Intervention

Sublingual tablet of ragweed pollen allergen extract

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Ragweed, allergy, sublingual immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DRC Drug Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks

Secondary Outcome Measures

Immunological markers (IgE and IgG4)

Full Information

NCT ID

NCT01224834

First Posted

October 13, 2010

Last Updated

November 5, 2010

Sponsor

Stallergenes Greer

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01224834

Brief Title

Safety and Tolerability Study of Ragweed SLIT Tablets

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 Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stallergenes Greer

Collaborators

Quintiles, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Seasonal, Ragweed Pollen Allergy

Keywords

Ragweed, allergy, sublingual immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sublingual tablet of ragweed pollen allergen extract

Intervention Description

administered once a day over 10 days

Primary Outcome Measure Information:

Title

Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Immunological markers (IgE and IgG4)

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Péterfai, MD

Organizational Affiliation

DRC Drug Research Center, Balatonfüred - Hungary

Official's Role

Principal Investigator

Facility Information:

Facility Name

DRC Drug Research Center

City

Balatonfüred

ZIP/Postal Code

H-8230

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability Study of Ragweed SLIT Tablets

We'll reach out to this number within 24 hrs