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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389363
First Posted: October 18, 2006
Last Update Posted: August 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ALK-Abelló A/S
  Purpose
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).

Condition Intervention Phase
Asthma Drug: ALK HDM tablet Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Use of inhaled corticosteroid (ICS).

Secondary Outcome Measures:
  • Use of rescue medication and symptoms.
  • Quality of Life.

Estimated Enrollment: 800
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389363


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD. ALK-Abelló
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00389363     History of Changes
Other Study ID Numbers: MT-02
First Submitted: October 17, 2006
First Posted: October 18, 2006
Last Update Posted: August 17, 2010
Last Verified: August 2010


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