Study to investigate how efficient and how safe are tablets of house dust mite allergens for patients with house dust mite allergic asthma

Phase 1

Conditions: house dust mite-associated allergic asthma
MedDRA version: 14.1Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870
MedDRA version: 14.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2013-000487-28-SK

Lead Sponsor: STALLERGENES SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 480

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 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

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, immunological disease and endocrine disease.
19. Participation in any clinical study within the 12 weeks before screening.
20. Investigators, co-investigators, as well as their children or spouses and all the study
collaborators.
21. Subject under protection of the courts, legal guardianship or legal trusteeship.
22. History of drug or alcohol abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the effect of one year of treatment with sublingual<br>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 Outcome Measures

Name	Time	Method

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