A clinical study conducted in several test centres to investigate the safety and tolerability of a year-round dosage of immune therapy with an Allergoid drug in patients with hay fever and or without controlled asthma.

Phase 1

• Conditions: Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma.; MedDRA version: 19.0Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870; MedDRA version: 19.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870; MedDRA version: 19.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 19.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 19.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855

• Registration Number: EUCTR2015-002409-13-DE
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-28
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Written informed consent given 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.Legally competent male or female outpatient
3.Age = 18 and = 65 years
4.IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without controlled allergic asthma caused by grass pollen as confirmed by the following test procedures:
•Skin prick test (SPT):
•wheal for 6-grasses pollens = 3 mm in diameter
•Histamine wheal = 3 mm (positive control)
•NaCl reaction < 2 mm (negative control)
•Immunoassay result for specific IgE = 0.70 kU/L to grass mix/earlybloom (central lab)
5.Main symptoms of allergic rhinitis or rhinoconjunctivitis between the months of May to August of at least 1 month with respective grass pollen exposure in the previous 2 seasons
6.Previous treatment with anti-allergic treatment for at least 2 seasons 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 240
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 participating in any other trial within 30 days before inclusion into this trial
3.Low compliance or inability to understand instructions/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 or any relationship with the sponsor or investigator
6.Mentally disabled
7.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 postmenopausal):
8.Positive pregnancy test at screening or during the course of the trial
9.Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
10.Wish to breastfeed
11.Wish to become pregnant during the course of the trial

Immunotherapy criteria:
12.AIT with grass pollen within the last 5 years
13.Currently under any sort of immunotherapy
14.AIT with unknown allergen within the last 5 years

Diseases and health status:
15.Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
16.Peak expiratory flow (PEF) < 70% of predicted normal (ECSC) under adequate asthma treatment according to GINA 2015
17.Uncontrolled or partly controlled asthma according to GINA 2015
18.Perennial and continuously treated asthma
19.Rhinoconjunctival atopic symptoms for 20 years or longer
20.Severe acute or chronic diseases (e.g. active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
21.Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease)
22.Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
23.Recurrent seizures
24.Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
25.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)
Medications:
26.Use of beta-blockers (locally or systemically)
27.Contraindication for use of adrenaline (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
28.Completion or ongoing treatment with anti-IgE-antibody
29.Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs
30.Use of prophylactic or continuous treatment with anti-allergic medication in fixed (constant) dose during the pollen season

Study & Design

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