Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

NCT ID: NCT00623701

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-10-31

Brief Summary

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Efficacy and Safety from a high-dosed sublingual grass pollen preparation

Detailed Description

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Conditions

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Allergy Rhinitis Conjunctivitis

Keywords

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sublingual grass pollen preparation IgE-mediated Allergic Disease attributed to grass pollen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

sublingual placebo preparation

Group Type PLACEBO_COMPARATOR

Allerslit forte

Intervention Type BIOLOGICAL

sublingual placebo preparation, daily

2

Sublingual preparation, 40 micro grams Phl p 5 maintenance dose

Group Type EXPERIMENTAL

Allerslit forte

Intervention Type BIOLOGICAL

Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily

Interventions

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Allerslit forte

sublingual placebo preparation, daily

Intervention Type BIOLOGICAL

Allerslit forte

Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation Test

Exclusion Criteria

* Serious chronic disease
* other perennial allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristian Reich, Professor

Role: PRINCIPAL_INVESTIGATOR

not affiliated

Locations

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Prof. Kristian Reich, MD

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.allergopharma.de

Leader in specific allergy research and therapy

https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-000823-16/DE

Click here for information about this trial in the European Clinical Trials Register

Other Identifiers

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2007-000823-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AL0703st

Identifier Type: -

Identifier Source: org_study_id