Clinical study conducted in several centers to investigate the safety of an accelerated dose escalation of immune therapy with an allergoid drug in patients with birch pollen allergy with or without controlled asthma

Phase 1

• Conditions: Patients with seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma during the birch pollen season; MedDRA version: 20.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; 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: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-005400-28-DE
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-18
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Informed consent given according to local requirements before any trial-related activity. (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
2. Legally competent male or female outpatient
3. Age between 18 to 65 years
4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without bronchial asthma caused by birch pollen documented by:
4a) SPT wheal for birch pollen = 3mm in diameter
4b) Histamine wheal = 3mm
4c) NaCl control reaction < 2mm
5. IgE result = 0.70 kU/L to birch pollen
6. At least 1 month with symptoms due to allergic rhinitis or rhinoconjunctivitis in the months March to May with birch pollen exposure
7. In case of bronchial asthma at entry: confirmed diagnosis of asthma
8. In case of a diagnosed asthma: asthma classified as being well controlled” according to GINA guideline (GINA, 2015)
9. Treatment with anti-allergic medications for at least 2 years prior to enrolment

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 120
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 participated in any other trial within 30 days before inclusion in this trial
3. Low compliance or inability to understand instructions or trial documents
4. Involvement 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. Previous randomization 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):
10. Positive pregnancy test or pregnant
11. Use of an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator (Reliable and methods of birth control defined as failure rate less than 1% per year)
12. Wish to breastfeed or breast feeding
13. Wish to become pregnant during the course of the trial
Immunotherapy criteria:
14. AIT with birch pollen allergens within the last 5 years
15. Current treatment with any kind of immunotherapy
16. AIT with unknown allergen within the last 5 years
Diseases and health status:
17. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
18. Peak expiratory flow (PEF) < 70% of predicted normal (European Coal and Steel Community) under adequate asthma treatment according to GINA guideline (GINA, 2015)
19. Uncontrolled or partly controlled asthma according to GINA guideline (GINA, 2015)
20. Rhinoconjunctival atopic symptoms for 20 years or longer
21. Severe acute or chronic diseases (e.g. diabetes mellitus type I, malignant neoplasia, chronic renal failure, active tuberculosis), severe inflammatory diseases (liver, kidneys)
22. Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, vitiligo, lupus erythematodes [SLE], Grave’s disease, multiple sclerosis)
23. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
24. Recurrent seizures
25. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
26. Laboratory value 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) (FDA, 2007)
Medications:
27. Use of ß-blockers (locally and systemically)
28. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
29. Completion or ongoing treatment with anti-IgE-antibody
30. Completion or onging long-term treatment with tranquilizer or other psychoactive drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified