house dust mite-associated allergic asthma MedDRA version: 14.1 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870 MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Product Name: Sublingual tablet of HDM Allergen Extracts
Pharmaceutical Form: Sublingual tablet
Other descriptive name: Dermatophagoides pteronyssinus allergen extract
Concentration unit: BAU Bioequiv
Sponsors
STALLERGENES SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained before completion of any study-related procedure. 2. Male or female from 18 to 50 years of age, in general good health apart from his/her asthma history, as determined by medical history, physical examination and routine laboratory tests. 3. Medical history consistent with HDM-induced allergic asthma for at least one year before screening, as supported by clear evidence of a relationship between asthma symptoms and exposure to HDM allergens (see Appendix III for the conduct of subject’s interview). 4. Medical history consistent with HDM-induced allergic rhinitis for at least one year before screening, as supported by clear evidence of a relationship between rhinitis symptoms and exposure to HDM allergens. 5. Wheal diameter induced by Skin Prick Test (SPT) to Dermatophagoides pteronyssinus or to Dermatophagoides farinae at least 5 mm greater than the negative control and HDM-specific IgE serum value = 0.7 kU/L. 6. Asthma therapies consistent with GINA treatment Step 2 to Step 4 provided that the controller medication consists of inhaled corticosteroid (ICS) alone or combined with long-acting beta (ß)-2 agonist (LABA) (according to GINA classification, 2012), unchanged for at least 12 weeks before screening. 7. Spirometry (pre-bronchodilator) with best FEV1 = 70% of the predicted value. 8. Spirometry with reversibility in FEV1 of = 12% and = 200 mL from the prebronchodilator value after inhalation of 200-400 mcg of salbutamol. If not recorded in the subject’s medical chart within two years prior to screening, FEV1 reversibility of = 12% and = 200 mL must be obtained at screening or during the screening period. 9. Asthma Control Test™ (ACT) score = 19. 10. Subject willing to comply with the protocol. 11. Routine safety laboratory tests results within acceptable range. 12. Asthma Control Test™ (ACT) score = 16 and = 19. 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 480 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with systemic corticosteroids within 12 weeks before screening. 2. Asthma exacerbation requiring hospitalisation within 12 weeks before screening. 3. Lower respiratory tract infection within 4 weeks before screening. 4. History of Intensive Care Unit admission or intubation for asthma. 5. History of anaphylaxis. 6. Previous treatment with anti-IgE therapy. 7. Former smoker with > 10 pack year history or current smoker. 8. A urine level of cotinine = 500 ng/mL. 9. Co-sensitisation to any perennial aeroallergen to which the subject is regularly exposed, and which could significantly change the asthma symptoms of the subject during the study. 10. Co-sensitisation to any seasonal aeroallergen to which the subject could be exposed during the primary period of evaluation (approximately November to February), for example, specifically excluded will be subjects sensitised to parietaria, ragweed, or mugwort, if this allergen is endemic to the investigative site’s region. 11. Allergen immunotherapy for HDM within the past 10 years. 12. Ongoing immunotherapy for an aeroallergen other than house dust mite. 13. Any oral condition that could confound the safety assessments i.e. oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis, or planning to have a dental extraction during the study. 14. Galactose intolerance. 15. Ongoing treatment with beta-blockers, tricyclic ntidepressants or monoamine oxidase inhibitors (MAOIs). 16. A serious immunopathologic condition or malignancy. 17. Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner). Women are considered not to have childbearing potential before their menarche, at least 2 years after menopause or if they have had a bilateral tubal ligation or a total hysterectomy or bilateral oophorectomy or ovariectomy. 18. Past or current disease, which as judged by the Investigator, may affect the subject’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, immunosuppression, immunological disease and endocrine disease. 19. Participation in any clinical study within the 12 weeks before screening. 20. Possible dependency of the subject on sponsor or investigators/subinvestigators or study collaborators 21. Treatment with systemic corticosteroids between screening and randomisation. 22. Asthma exacerbation requiring hospitalisation between screening and randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of one year of treatment with sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts at a daily dosage of 100 IR, 500 IR or 1000 IR as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma.;Secondary Objective: determine the effect and the safety of immunotherapy tablets of HDM allergen extracts administered sublingually at a daily dosage of 100 IR, 500 IR or 1000 IR as compared to placebo;Primary end point(s): Change of ACT Score from baseline;Timepoint(s) of evaluation of this end point: visit 7 or early termination provided the IP has been taken for at least 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Subjects achieving asthma control according to ACT score 2.Subjects with at least a 3-point improvement in ACT score 3.Daily and average daytime asthma symptom scores 4.Daily and average nighttime asthma symptom scores 5.Asthma rescue medication use 6.Asthma rescue medication score 7.Proportion of asthma symptom- and rescue medication-free days 8.Asthma exacerbations 9.Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) 10.SF-12 Health Survey 11.Controlled weeks 12.Six individual daily and average rhinoconjunctivitis symptom scores 13.Daily and average rhinitis total symptom scores 14.Daily and average conjunctivitis total symptom scores 15.Daily and average rhinoconjunctivitis total symptom scores Rhinoconjunctivitis rescue medication usage 16.Daily and average rhinitis adjusted symptom scores 17.Daily and average rhinoconjunctivitis adjusted symptom scores 18.Daily and average rhinoconjunctivitis rescue medication scores 19.Daily and average rhinitis combined scores 20.Daily and average rhinoconjunctivitis combined scores 21.Proportion of rhinoconjunctivitis symptom-controlled days (PSCDs) 22.Controlled patients (CPs) regarding rhinoconjunctivitis 23.Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) ;Timepoint(s) of evaluation of this end point: endpoint 1: Visit 7 or early termination endpoints 2 to 7 and 12 to 23: visit 7 endpoint 8: 1 year treatment endpoint 9: visits, 5, 6, 7 and EOT endpoint 11: weekly for the 12 previous weeks to visit 7 | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Poland, Slovakia, Spain, United Kingdom
Contacts
Public ContactGlobal Clinical Department
Stallergenes S.A
Outcome results
None listed