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

This study has been completed.
Information provided by:
ALK-Abelló A/S Identifier:
First received: October 17, 2006
Last updated: August 16, 2010
Last verified: August 2010
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
Drug: ALK HDM tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

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

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
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Please refer to this study by its identifier: NCT00389363

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00389363     History of Changes
Other Study ID Numbers: MT-02
Study First Received: October 17, 2006
Last Updated: August 16, 2010 processed this record on May 25, 2017