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

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. Identifier: NCT00389363
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : August 17, 2010
Information provided by:
ALK-Abelló A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: ALK HDM tablet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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%

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 identifier (NCT number): NCT00389363

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Copenhagen, Denmark, 2100
Sponsors and Collaborators
ALK-Abelló A/S
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Study Director: Kim Simonsen, MD. ALK-Abelló
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00389363    
Other Study ID Numbers: MT-02
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: August 2010