Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

February 7, 2013 updated by: ALK-Abelló A/S

A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ

The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

473

Phase

  • Phase 2

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
    • Thueringen
      • Erfurt, Thueringen, Germany, D-99084
        • Allergists' practice Dr. Kirsten Jung

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
  • Lack of adequate relief with symptomatic medication during the previous grass pollen season
  • Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria:

  • FEV1 < 70% of predicted value at screening
  • Bronchial asthma corresponding to GINA step 3 or more, even if controlled
  • History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
  • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
  • Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: subcutaneous immunotherapy
subcutaneous immunotherapy using a slow updosing schedule
Biological: subcutaneous immunotherapy
7 injections
Other Names:
  • AVANZ
Active Comparator: subcutaneous injections
subcutaneous immunotherapy using a fast updosing schedule
Biological: subcutaneous immunotherapy
7 injections
Other Names:
  • AVANZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IgE-blocking factor
Time Frame: start of treatment and 1 week after end of treatment
start of treatment and 1 week after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability of two different updosing schedules
Time Frame: throughout treatment
throughout treatment

Collaborators and Investigators

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

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Kirsten Jung, MD, Private practice, Erfurt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF-H-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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