Study to investigate the safety of a short (fast) dose escalation in immune therapy with house dust mite allergens as compared to the approved long (slow) dose escalation in adult and adolescent patients with allergic cold (with and w/o asthma).
- Conditions
- moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthmaMedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-004328-41-PL
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 140
1. Written informed consent given from patient (and parents/legal guardian(s), as applicable)
2. Age between 12 and = 65 years
3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by house dust mite allergens (established and documented as part of the screening procedures)
4. Symptoms of allergic rhinitis or rhinoconjunctivitis triggered by house dust mite exposure over at least the last 2 years
5. No diagnosis of bronchial asthma in medical history, or confirmed diagnosis of asthma as being well controlled”
6. Previous symptomatic anti-allergic treatment for at least 2 years prior to enrolment
7. Negative SARS-CoV-2 test result
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 69
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
General criteria:
1. Patients and if relevant parents/legal guardian(s) are unable to understand and comply with the requirements of the trial, as judged by the investigator
2. Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
3. Low adherence to trial procedures expected or inability to understand instructions/trial documents by participant and/or parents/legal guardian(s)
4. Involvement in the planning and conduct of the trial
5. Patients and if relevant parent/legal guardian is employee of Allergopharma GmbH & Co. KG or of one of the trial sites or CRO
6. Any relationship of dependence with the sponsor or with the investigator
7. Previous randomization to treatment in the present trial
8. Mentally disabled
9. Institutionalized due to an official or judicial order
For female patients with childbearing potential
10. Positive urine pregnancy test or pregnant
11. Wish to become pregnant during the course of the trial
12.Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
13. Wish to breast feed or breast feeding
Immunotherapy criteria:
14. History of a confirmed anaphylaxis after an AIT injection
15. AIT with house dust mite allergoids or allergens within the last 5 years
16. Current treatment with any kind of allergen immunotherapy (AIT)
17. AIT with unknown allergen within the last 5 years Diseases and health status:
18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to
GINA recommendation (GINA 2020)
20. Uncontrolled or partly controlled asthma according to GINA recommendation (INA 2020)
21. Acute asthma attack within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency visit
22. Severe acute or chronic diseases (e.g. COVID-19, chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys), acute viral and bacterial infections presenting with fever
23. Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis)
24. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
25. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy)
26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
27. For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patient.
Medications:
28. Use of ß-blockers (locally or systemically), ACE inhibitors
29. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heartdisease, severe hypertension)
30. Completion or ongoing treatment with anti-IgE-a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method