House Dust Mite Allergy Clinical Trial
— MT-06Verified date | January 2017 |
Source | ALK-Abelló A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 992 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Department of Respiratory Diseases, Lapeyronie Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
ALK-Abelló A/S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of allergy symptoms and use of symptomatic medication | 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. | 1 year with treatment |
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