A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet

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.

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Key information

Conditions

House Dust Mite Allergy Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Respiratory Diseases, Lapeyronie Hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AIT Tablet

Biological

1 tablet per day in 12 months

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Acronym: MT-06

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Oct 19, 2011
Registry last updated: Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed