Phase III trial of specific immunotherapy with allergoid preparation of house dust mite in patients with allergic bronchial asthma and with allergic rhinitis or rhinoconjunctivitis

Phase 1

Conditions: allergic bronchial asthma and allergic rhinitis or rhinoconjunctivitis
MedDRA version: 20.0Level: LLTClassification code 10039097Term: RhinoconjunctivitisSystem Organ Class: 100000004862
MedDRA version: 20.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855
MedDRA version: 20.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2015-000188-15-AT

Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 446

Inclusion Criteria

1. Written informed consent and assent according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
2. Male or female outpatient between 12 and 65 years (both inclusive), but Italy and Russia: 18 - 65 years only
3. IgE-mediated allergic bronchial asthma treated according GINA step 2-4 with rhinitis or rhinoconjunctivitis induced by house dust mite documented by
• SPT wheal for D p = 3 mm in diameter
• histamine (0.1% histamine) wheal = 3 mm
• a negative control reaction (NaCl) wheal < 2 mm
• Immunoassay result specific IgE > 1.5 kU/L to D p
• symptoms of asthma and rhinitis or rhinoconjunctivitis e.g. during the months September to February or over the entire year
4. confirmed diagnosis of asthma
• treatment according to GINA 2016 during the last year as documented by requirement of ICS and in addition, either the requirement of a long acting bronchodilator or as-needed of a short acting bronchodilator
• FEV1 increase of = 12% and 200 mL of the baseline FEV1 after inhalation of 400µg of Salbutamol or other short acting bronchodilator equivalent (historical data not older than 2 years are acceptable. A methacholine test (= 20% FEV1 decrease after Methacholine provocation test) in the historical data is acceptable)
• Achievement of asthma control criteria (ACQ6 = 1.0 scores in 2 consecutive weeks at the end of the assessment period) during the baseline diary phase within a required ICS dose between 400 to 1200 µg Budesonide per day

Are the trial subjects under 18? yes
Number of subjects for this age range: 133
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 313
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General criteria:
1. Unable to understand and comply with the requirements of the trial, as judged by the investigator
2. Currently participating in any other trial or in participating in any other trial within 30 days before inclusion in this trial
3. Low compliance, persistent incorrect inhaler technique as assessed by the investigator or inability to understand instructions or trial documents
4. Involved in the planning and conduct of the trial
5. Employee of Allergopharma GmbH & Co. KG or of one of the trial sites
6. Any relationship of dependence with the sponsor or with the investigator
7. Previously enrolled or randomized to treatment in the present trial
8. Mentally disabled
9. Institutionalized due to an official or judicial order
For females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not post-menopausal [defined as 12 months with no menses without an alternative medical cause]):
10. Positive pregnancy test
11. Use of an unacceptable or unreliable contraceptive method as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year [CTFG recommendations 15 Sep 2014]) during the trial. Sexual abstinence is an allowed method of birth control (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.)
Males are not required to use any contraception during the study.
12. Pregnant, breast feeding or wishes to breast feed
13. Seeking to become pregnant during the course of the trial
Immunotherapy criteria:
14. Any AIT with house dust mites
15. Current treatment with any kind of immunotherapy
16. Any AIT with unknown allergen
17. Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals.
18. Sensitization in the immunoassay = 0.7 kU/L against perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are sensitizations to storage mites if the sensitization assessed by immunoassay is lower than the sensitization to at least one of the house dust mites (D p or D f). Exceptions are sensitizations assessed by immunoassay to cat and dog, if the patient has no direct contact to these animals.
Diseases and health status:
19. Clinically relevant rhinitis or respiratory symptoms related to other reasons (e.g. chronic sinusitis, COPD)
20. FEV1 < 70% of predicted normal (ECSC) at best asthma control
21. Chronic, persistent asthma or rhinitis symptoms for 20 years or longer
22.Laboratory values greater than Grade 1 (for hematological values Grade 2) according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials). For assessment the normal ranges of the central laboratory will be applied.
23.Severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure, gastro-esophageal reflux disease, BMI > 30, aspirin induced asthma, active tu

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this clinical trial is to demonstrate efficacy and to evaluate safety of AIT with an aluminium hydroxide adsorbed allergoid preparation of major allergens of D p in patients with allergic bronchial asthma (acc. to GINA 2016) and allergic rhinitis or rhinoconjunctivitis caused by house dust mites.;Secondary Objective: None;Primary end point(s): This is a confirmatory phase III pivotal study. The primary endpoint is the change in dose steps of the minimum daily ICS dose required to ensure asthma control (well controlled or partly controlled)according to the ACQ6 (ACQ6 score = 1.0) between baseline and after AIT. The ICS dose will be determined by means of diary entries as described in Section 5.1.;Timepoint(s) of evaluation of this end point: after the end of the trial

Secondary Outcome Measures

Name	Time	Method

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