In a clinical trial in approx. 15 trial sites in Germany the efficacy, safety and evaluation of the specific and non specific effects of a treatment with either Allergovit® grasses or Allergovit® birch in patients with grass and birch pollen allergy will be compared.
- Conditions
- Patients suffering from seasonal allergic rhinoconjunctivitis with or without controlled asthma during the birch and grass pollen seasonMedDRA version: 17.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853MedDRA version: 17.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-003095-12-DE
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 years?
4.Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen and birch pollen allergy documented by
a)Skin prick test wheal for grass pollen = 3mm in diameter
b)Skin prick test wheal for birch pollen = 3mm in diameter
c) Histamine wheal = 3mm
d) NaCl control reaction < 2mm?
5. Has the patient an immunoassay result
a)for sIgE > 0.70 kU/L to grass pollen allergens?
b)for sIgE > 0.70 kU/L to birch pollen allergens?
6.Has the patient main discomfort due to allergic rhinoconjunctivitis in the months with respective grass pollen and birch pollen exposure?
7.Has the asthma status been checked?
8.Has the patient been treated with anti-allergic medications for at least 2 years prior to enrolment?
Prior to the treatment phase the Sponsor will assess following criterion:
9.Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with birch pollen allergens in the ECC?
10.Does the patient suffer from relevant symptoms (adj. AUC of TNSS of at least 10) documented during the pre-treatment exposure with grass pollen allergens in the ECC?
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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 GmbH & Co. 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.Does the patient wish to breast feed?
13.Is the patient seeking to become pregnant during the course of the study?
Immunotherapy criteria:
14.Has the patient undergone previous specific immunotherapy with grass pollen or birch pollen allergens in any formulation?
15.Is the patient currently undergoing any sort of specific immunotherapy?
16.Has the patient ever undergone specific immunotherapy with unknown allergens?
Diseases and health status:
17.Does the patient suffer from clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons which interfere with the assessments in the ECC?
18.Has the patient a PEF/FEV1 < 80% of predicted normal (ECSC)?
19.Has the patient uncontrolled or partly controlled asthma according to GINA 2012?
20.Does the patient suffer from perennial and continuously treated asthma?
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), 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)?
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 an anatomic abnormality that interferes with assessment of Total Nasal Symptom Score (TNSS) if being assessed in the environmental challenge chamber?
27.Has the patient any 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)?
Medications:
28.Is the patient permanently needing any me
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to demonstrate a specific treatment effect for ALLERGOVIT® grasses and ALLERGOVIT® birch.<br>;Secondary Objective: The main secondary objective of this study is to assess the superiority of the specific treatment effect of SCIT compared to the unspecific treatment effect.<br>Please refer to section 5.2 for further objectives;Primary end point(s): •Specific treatment effect of ALLERGOVIT® grasses<br>•Specific treatment effect of ALLERGOVIT® birch<br>;Timepoint(s) of evaluation of this end point: Evaluation after database lock approx. Feb 2016 under blended conditions
- Secondary Outcome Measures
Name Time Method