Safety study comparing 2 uptitration schemes with Allergovit® grasses

Active, not recruiting

• Conditions: ICD classificationcode: J 45.0 and J30.1Patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without controlled bronchial asthma; MedDRA version: 14.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001914-41-DE
• Lead Sponsor: Allergopharma Joachim Ganzer KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-03
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
2.Is the patient a legally competent male or female outpatient?
3.Is the patient aged 18 to 65 year?
4.Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen documented by
•4 a) Skin prick test wheal for grass pollen = 3mm in diameter
•4 b) Histamine wheal = 3mm
•4 c) NaCl control reaction < 3mm
5.IgE result = 0.70 kU/L to grass pollen
6.Has the patient main discomfort due to allergic rhinoconjunctivitis in the months with grass pollen exposure?
7.In case of bronchial asthma at entry: Has the patient a confirmed diagnosis of asthma?
8.In case of a diagnosed asthma, is the asthma classified as being controlled” according to GINA guidelines (GINA, 2006)?
9.Has the patient been treated with anti-allergic medications for at least 2 years prior to enrolment? (Patients with perennial and continuously treated asthma have to be excluded, see exclusion criteria” below.)

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.Is the patient unable to understand and comply with the requirements of the trial, as judged by the investigator?
2.Is the patient currently participating in any other trial or has the patient participated in any other trial within 30 days before inclusion in this trial?
3.Does the patient show low compliance or inability to understand instructions/trial documents?
4.Is/was the patient involved in the planning and conduct of the trial?
5.Is the patient an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites?
6.Is the patient in any relationship of dependence with the sponsor and/or with the investigator?
7.Has the patient been previously enrolled or randomised to treatment in the present trial?
8.Is the patient mentally disabled?
9.Is the patient institutionalised due to an official or judicial order?

For females with childbearing potential (i.e. females who are not chemically or surgically sterilised or females who are not post-menopausal):
10.Does the patient have a positive pregnancy test at screening?
11.Does the patient use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator? (Reliable and highly effective methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly are, e.g., implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners.)
12.Is the patient pregnant or wishes to breast feed?
13.Is the patient seeking to become pregnant?

Immunotherapy criteria:
14.Has the patient undergone previous specific immunotherapy with grass pollen allergens in any formulation?
15.Is the patient currently undergoing any sort of immunotherapy?

Other allergies:
16.Has the patient an (anamnestically confirmed) clinically relevant sensitisation to
a) Dermatophagoides farinae
b) Dermatophagoides pteronyssinus
c) birch pollen,
d) alder pollen,
e) hazel pollen
and is any of the Skin Prick Test results greater than the result for grass pollen?

17.Has the patient an (anamnestically confirmed) clinically relevant sensitisation to
a) cat epithelia
b) dog epithelia
c) Dermatophagoides farinae
d) Dermatophagoides pteronyssinus
e) birch pollen,
f) alder pollen,
g) hazel pollen
and is any of the spec. IgE results greater than the result for grass pollen?

Diseases and health status:
18.Has the patient a PEF or FEV1 < 80% of predicted normal (ECSC)?
19.Does the patient suffer from perennial asthma?
20.Has the patient uncontrolled or partly controlled asthma according to GINA guidelines (GINA, 2006)?
21.Does the patient suffer from rhinoconjunctival atopy symptoms for 20 years or longer?
22.Does the patient suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure, active Tuberculosis), severe inflammatory diseases (liver, kidneys)?
23.Does the patient suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave’s disease, Hashimoto’s thyroiditis, Multiple Sclerosis)?
24.Does the patient suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)?
25.Does the patient suffer from recurrent seizures?
26.Has the patient any laboratory value

Study & Design

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