Study of Specific Allergen Immunotherapy in Grass Pollen... | NCT00719511

Studies
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration

NCT00719511

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 17, 2011Estimated

Enrollment

132Estimated

Phase

Phase 2

Conditions

Allergies

Interventions

Purified allergen dose 1 integrated in a Patch system
Purified allergen dose 2 integrated in a Patch system
Purified allergen dose 3 integrated in a Patch system
Purified allergen integrated in a Patch system

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 17, 2008

First Submission Date that Met QC Criteria

Jul 18, 2008

First Posted Date

Jul 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patch allergen dose 1	Drug: Purified allergen dose 1 integrated in a Patch system
2	Experimental	Patch allergen dose 2	Drug: Purified allergen dose 2 integrated in a Patch system
3	Experimental	Patch allergen dose 3	Drug: Purified allergen dose 3 integrated in a Patch system
4	Experimental	Placebo	Drug: Purified allergen integrated in a Patch system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Purified allergen dose 1 integrated in a Patch system	Drug	Epicutaneous application of a patch	1

Measure	Description	Time Frame
Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment		2010

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Written informed consent
History of grass pollen allergic rhinitis
Male and female between 18 years to 65 years
Positive skin-prick test to grass pollen
Positive conjunctival provocation test

Exclusion criteria:

Eczematous skin lesions on the upper arms
Perennial allergic rhinitis
Symptoms of infectious disease with rhinitis in between the last 2 weeks
Surgical intervention in between the last 30 days
Pregnancy or nursing
History of HIV or AIDS
History of mastocytosis (cutaneous or systemic)
History of significant cardiovascular disease
Hypertension (blood pressure > 160 / 95)
History of significant pulmonary, renal and/or hepatic disease
History of significant hematological disorder
Moderate or severe asthma
History of malignancy
History of neurological or psychiatric disease
History of autoimmune disease
Antihistamines with longed half-lives in the last week
Systemic or topical steroids for 5 days
Active infectious disease
Contraindicated medications:
- immunosuppressive agents
- Betablockers
- ACE-inhibitors, AT 2 Antagonists
- tricyclic antidepressants
- daily use of Beta-agonists or steroid inhalers
Participation in another clinical trial /study at the moment or within the last 60 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided