Study to investigate the safety of an accelarated (fast) dose escalation schedule using one strength birch pollen allergens as compared to the approved long (slow) two-dose escalation in adult and pediatric patients with allergic cold (with and w/o asthma).
- Conditions
- moderate to severe seasonal allergic rhinitis or rhinoconjunctivitis with or w/o asthma caused by birch pollen allergensMedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-002317-34-PL
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 210
1. Written informed consent given from patient and if relevant parents/legal guardian(s) according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during routine management of the patient)
2. Age between 5 and = 65 years
3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by sensitization to birch pollen allergens documented by:
• Positive Skin prick test (SPT) result to birch pollen allergens:
- Birch pollen test solution (wheal diameter) = 3 mm and
- Positive histamine-control reaction (wheal diameter) = 3 mm and
- Negative NaCl 0.9%-control reaction (wheal diameter) < 2 mm
• Moderate to severe rhinitis acc. to ARIA guideline (Brozek et al. 2017, Bousquet et al. 2001)
• Immunoassay result for specific IgE = 0.70 kU/L to birch pollen allergens
4. Symptoms of allergic rhinitis or rhinoconjunctivitis from March to May on birch pollen exposure during the last 2 seasons
5. At entry to this trial: no diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma which is well controlled” according to GINA recommendation (GINA 2021)
6. Previous symptomatic anti-allergic treatment for at least 2 seasons prior to enrolment
7. Negative SARS-CoV-2 test result (PCR or antigen test) during the screening period
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
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 participation in another clinical trial or participation in any other clinical trial within 30 days prior to 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 parents/legal guardian(s) is/are employee(s) 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(s)
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 of 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 birch pollen 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 et al. (2012) under adequate asthma treatment according to GINA recommendation (GINA 2021)
20. Uncontrolled or partly controlled asthma according to GINA recommendation
(GINA 2021)
21. Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use
of systemic corticosteroid or change in controller medication
22. Severe acute or chronic diseases (e.g. COVID-19, chronic urticaria, mastocytosis, 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-complex-induced 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 patients. Generally, this applies to patients of all age groups in this trial. However, for laboratory values with age specific re
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