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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
October 17, 2006
October 18, 2006
August 17, 2010
August 2006
April 2008   (Final data collection date for primary outcome measure)
Use of inhaled corticosteroid (ICS).
Same as current
Complete list of historical versions of study NCT00389363 on ClinicalTrials.gov Archive Site
  • Use of rescue medication and symptoms.
  • Quality of Life.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects
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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Asthma
Drug: ALK HDM tablet
Not Provided
Mosbech H, Canonica GW, Backer V, de Blay F, Klimek L, Broge L, Ljørring C. SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms. Ann Allergy Asthma Immunol. 2015 Feb;114(2):134-40. doi: 10.1016/j.anai.2014.11.015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
April 2008
April 2008   (Final data collection date for primary outcome measure)

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%
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00389363
MT-02
Not Provided
Not Provided
Not Provided
Not Provided
ALK-Abelló A/S
Not Provided
Study Director: Kim Simonsen, MD. ALK-Abelló
ALK-Abelló A/S
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP