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
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00389363     History of Changes
Other Study ID Numbers: MT-02 
Study First Received: October 17, 2006
Last Updated: August 16, 2010
Health Authority: Denmark: Danish Medicines Agency
Italy: The Italian Medicines Agency
Poland: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 26, 2016