Efficacy and Safety of Subcutaneous Immunotherapy in Birc... | NCT00410930

Studies
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

NCT00410930

Sponsor

Stallergenes Greer

Status

Terminated

Last Update Posted

Dec 19, 2006Estimated

Enrollment

160

Phase

Phase 2

Conditions

Allergy

Interventions

Subcutaneous immunotherapy - Recombinant birch pollen

Countries

France

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Dec 12, 2006

First Submission Date that Met QC Criteria

Dec 12, 2006

First Posted Date

Dec 13, 2006Estimated

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

Dec 15, 2006

Last Update Posted Date

Dec 19, 2006Estimated

Description Module

Brief Summary

To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous immunotherapy - Recombinant birch pollen	Biological

Measure	Description	Time Frame
Reduction of symptom and medication scores.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
Compliant patients
Written consent.

Exclusion Criteria:

Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
Patients treated with beta-blockers or under continuous oral corticosteroids.
Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabrielle PAULI, MD, Pr	Hôpital Liautey - Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pr Gabrielle PAULI		Strasbourg		67091	France