Avanz Phleum Pratense Maintenance Dose

NCT ID: NCT01438827

Last Updated: 2014-01-22

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

PHASE2/PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.

Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Avanz Phleum pratense 15,000 SQ+

Group Type ACTIVE_COMPARATOR

Avanz Phleum pratense

Intervention Type DRUG

Suspension for Injection, Every 6 weeks for one year

Avanz Phleum pratense 4,000 SQ+

Group Type ACTIVE_COMPARATOR

Avanz Phleum pratense

Intervention Type DRUG

Suspension for Injection, Every 6 weeks for one year

Injection with no active grass component

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension for Injection, Every 6 weeks for one year

Interventions

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Avanz Phleum pratense

Suspension for Injection, Every 6 weeks for one year

Intervention Type DRUG

Placebo

Suspension for Injection, Every 6 weeks for one year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A history of grass pollen allergy
* Positive skin prick test to grass
* Positive Immunoglobulin E test to grass

Exclusion Criteria

* Other allergies overlapping the grass pollen season
* Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jörg Kleine-Tebbe, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center for Dermatology, Allergy and Asthma

Locations

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UntersuchungsZentrum für Dermatologie, Allergologie und Asthma

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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AV-G-02

Identifier Type: -

Identifier Source: secondary_id

AV-G-02

Identifier Type: -

Identifier Source: org_study_id

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