House dust mite allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Product Name: Allergen extract of house dust mites
Product Code: Dermatophagoides pteronyssinus allergen extract
Pharmaceutical Form: Sublingual tablet
Current Sponsor code: Dermatophagoides pteronys
Sponsors
Stallergenes S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and Criteria for Inclusion: Inclusion criteria: 1. Male or female outpatients aged 18 to 50 years (inclusive). 2. Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements. 3. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests. 4. Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method. 5. Negative urine pregnancy test on female patients of childbearing potential. 6. House dust mite-related allergic rhinitis for at least 1 year. 7. Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level = 0.7 kU/L). 8. Baseline ARTSS =5 (after completion of the 7-day daily record card). 9. Patients who are willing to comply with the protocol. 10. Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Whatever the considered allergens, co-sensitisation leading to clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites). 2. Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis). 3. Patients sensitised to cat or dog allergens and living with these animals at home. 4. Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. 5. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1). 6. Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1. 7. Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2. 8. FEV1 < 80% of predicted value at Visit 1. 9. Patients who received allergy specific immunotherapy for house dust mites in the last 10 years. 10. Patients at risk of non-compliance. 11. Participation in any clinical study within the 12 weeks before Visit 1. 12. Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study. 13. Any change in environmental measures for allergen avoidance during the study. 14. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease. 15. Patients treated with beta-blockers or under continuous corticotherapy. 16. Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies. 17. Ongoing treatment by immunotherapy with another allergen. 18. Patients with a history of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 12 months of SLIT on the Average Rhinitis Total Symptom Score (ARTSS) of the four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion To document the safety of 12 months of SLIT as well as the safety of a further 12 months treatment free follow-up.;Secondary Objective: Secondary Efficacy: To assess the efficacy of 12 months of SLIT on the: Average Rescue Medication Score (ARMS) (antihistamine [oral and eye drops], nasal corticosteroids and oral corticosteroids). Average Combined Score (ACS) – a score taking into account the Rhinitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS). Five individual Average Symptom Scores (ASS) (sneezing, rhinorrhoea, nasal pruritus, nasal congestion and ocular itching). Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score. Global evaluation of the efficacy of SLIT by the patient. Skin prick test (SPT) specific for house dust mites (D. pteronyssinus and D. farinae). Immunological markers (immunoglobulin IgE and IgG4) specific for house dust mite allergens. Asthma assessments. Sensitisation (mono-sensitivity to house dust mites only or poly-sensitivity [other allergens]). Onset of action of SLIT. ;Primary end point(s): Criteria for Evaluation: Primary Efficacy Variable: The primary efficacy variable will be the ARTSS at endpoint, with endpoint defined as the rhinitis symptom data collected between Visit 8 and Visit 9 during the Treatment Phase. • The RTSS is defined as the sum of the sneezing, rhinorrhoea, nasal pruritus and nasal congestion scores as evaluated by the patient, using a score from 0 to 3: 0 = Absent symptoms (no sign / symptom evident). 1 = Mild symptoms (sign / symptom clearly present, but minimal awareness; easily tolerated). 2 = Moderate symptoms (definite awareness of sign / symptom that is bothersome but tolerable). 3 = Severe symptoms (sign / symptom that is hard to tolerate; causes interference with activities | — |
Countries
Czech Republic, France, Germany, Netherlands, Slovakia, Spain
Outcome results
None listed