Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01454544
First received: October 13, 2011
Last updated: March 21, 2014
Last verified: March 2014
  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: Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

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 [ Designated as safety issue: No ]
    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.


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT01454544

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

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01454544     History of Changes
Other Study ID Numbers: MT-06
Study First Received: October 13, 2011
Last Updated: March 21, 2014
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 27, 2014