Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002277-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK house dust mite tablet 6 DU | Experimental |
| |
| ALK house dust mite tablet 12 DU | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIT Tablet | Biological | 1 tablet per day in 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory Diseases, Lapeyronie Hospital | Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29656145 | Derived | Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12. |
| Label | URL |
|---|---|
| SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitis | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012140 |
| Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |