We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet (MT-06)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454544
First Posted: October 19, 2011
Last Update Posted: January 30, 2017
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 (Responsible Party):
ALK-Abelló A/S
  Purpose

The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.


Condition Intervention Phase
House Dust Mite Allergy Biological: AIT Tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of allergy symptoms and use of symptomatic medication [ Time Frame: 1 year with treatment ]
    Comparing the daily recording of symptoms and use of symptomatic medication during the last period of the trial between the actively treated patients and the placebo treated.


Enrollment: 992
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALK house dust mite tablet 6 DU Biological: AIT Tablet
1 tablet per day in 12 months
Experimental: ALK house dust mite tablet 12 DU Biological: AIT Tablet
1 tablet per day in 12 months
Placebo Comparator: Placebo Biological: AIT Tablet
1 tablet per day in 12 months

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A history of house dust mite allergy
  • Use of symptomatice medication for treatment of house dust mite allergy
  • Positive skin prick test to mites
  • Positive specific IgE

Exclusion Criteria:

  • History of uncontrolled asthma
  • Overlapping symptomatice allergies
  • Previous treatment with immunotherapy
  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): NCT01454544


Locations
France
Department of Respiratory Diseases, Lapeyronie Hospital
Montpellier, France, 34295
Sponsors and Collaborators
ALK-Abelló A/S
  More Information

Additional Information:
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01454544     History of Changes
Other Study ID Numbers: MT-06
2011-002277-38 ( EudraCT Number )
First Submitted: October 13, 2011
First Posted: October 19, 2011
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases