Avanz Phleum Pratense Maintenance Dose

January 20, 2014 updated by: ALK-Abelló A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • UntersuchungsZentrum für Dermatologie, Allergologie und Asthma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Avanz Phleum pratense 15,000 SQ+
Drug: Avanz Phleum pratense
Suspension for Injection, Every 6 weeks for one year
Active Comparator: Avanz Phleum pratense 4,000 SQ+
Drug: Avanz Phleum pratense
Suspension for Injection, Every 6 weeks for one year
Placebo Comparator: Injection with no active grass component
Drug: Placebo
Suspension for Injection, Every 6 weeks for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recording of rhinoconjunctivitis symptoms
Time Frame: Daily recordings during the grass pollen season 2012
Daily recordings during the grass pollen season 2012
Recording of symptomatic allergy medication use
Time Frame: Daily recordings during the grass pollen seasons 2012
Daily recordings during the grass pollen seasons 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Jörg Kleine-Tebbe, PD Dr., Clinical Research Center for Dermatology, Allergy and Asthma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • AV-G-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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