Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects

August 16, 2010 updated by: ALK-Abelló A/S

A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients

The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A history of house dust mite induced asthma
  • Use of inhaled corticosteroids (ICS)
  • Positive skin prick test to house dust mites
  • Positive specific IgE to house dust mites

Exclusion Criteria:

  • FEV1 lower than 70%

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Use of inhaled corticosteroid (ICS).

Secondary Outcome Measures

Outcome Measure
Use of rescue medication and symptoms.
Quality of Life.

Collaborators and Investigators

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

Sponsor

ALK-Abelló A/S

Investigators

  • Study Director: Kim Simonsen, MD., ALK-Abello

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

August 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 18, 2006

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 16, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • MT-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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