Intermittent rhinitis and/or rhinoconjunctivitis with or without asthma bronchial caused by clinical relevant sensitisation against grass pollen. MedDRA version: 8.1 Level: LLT Classification code 10039083 Term: Rhinitis
Conditions
Interventions
Product Name: Depigoid Gräser-Mix
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: Freeze-dried depigmented and glutaraldehyde-polymerised aller
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Prior to study specific examinations the patient has to give his/her written informed consent 2.Patients (= 12 years old) with a history of moderate to severe intermittent rhinitis and/or rhinoconjunctivitis during the grass season according to ARIA classification (28) 3.Symptoms more than 2 years prior to study start 4.Detectable specific IgE = 2 CAP RAST to grass pollen at the screening visit (V1) or within the previous 12 months 5.Positive skin-prick test (wheal diameter of at least 3 mm > negative control; Phleum pollen, 30 HEPL/ml; Laboratorios LETI, S.L, Tres Cantos, Spain) Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease specific criteria 1.History of significant clinical manifestations of allergy as a result of sensitiza-tion against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite) For clarification: According to the decision tree (see Appendix 3) patients with typical symptoms against the co-allergens birch, house dust mite, cat and dog are not allowed to en-ter the trial. Patients without symptoms will enter the trial if they are not exposed to the allergen even if CAP RAST is = 2. In case they are exposed to the allergen they must have a specific CAP RAST < 2 to be able to enter the trial. 2.Persistent asthma (GINA = II) according to ARIA classification (29) 3.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value Patients with other known concomitant diseases / treatments 4.Active tuberculosis 5.Acute and chronic inflammatory or infectious diseases at the target organ effective 6.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis) 7.Autoimmune disorders (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) 8.Immune deficiencies 9.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism) 10.Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant 11.History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin 12.Abnormal laboratory parameters and vital signs that could increase the risk to the study participant 13.Alcohol, drug or medication abuse within the past year 14.Severe psychiatric / psychological / neurologic disorders Patients with other known previous / concomitant treatments The following therapy is not allowed within the specified period prior to screening as well as during the study and will prevent the patient from being included into the study: 15.SIT against grass pollen within the last 5 years 16.7 days prior and 14 days post an immunization with vaccines 17.Anti-allergic treatment within the last 4 weeks prior to screening 18.b-blocker are not allowed during the entire study and will lead to the patient being withdrawn 19.Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn 20.Use of other investigational drugs at the time of enrolment or within 30 days 21.Treatment with systemic corticosteroids within 3 months prior to the study Others 22.Patients who are expected to be non-compliant and/or not co-operative 23.Participation in any other clinical study within the last 30 days prior to the start of the study 24.Patients who have already participated in this study 25.Patients who are employees at the investigational site, relatives or spouses of the investigator 26.Any donation of germ cells, blood, organs, or bone marrow during the course of the study 27.Patients who are not contractually capable Special restrictions for female patients 28.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation 29.Women of child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized to grass pollen. Primary criterion Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season) ;Secondary Objective: Secondary criteria ·Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the first season) ·Symptom load for asthma (combined symptom and medication scores) in both seasons ·Titrated specific nasal challenge test at selected centers ·Titrated skin prick test ·Symptom scores (rhinitis and/or rhinocojunctivitis and asthma sepa-rately) on a scale from 0-3 (none – severe) in both seasons ·Rhinitis/Rhinoconjunctivitis ·Obstruction ·Sneezing ·Rhinorrhea ·Nasal itching ·Ocular itching ·Asthma ·Chest tightness .Shortness of breath ·Cough ·Wheezing ·Percentage of symptom improvement according to symptom score ·Medication scores in both seasons ·Rhinitis and/or rhinoconjunctivitis ·H1-blocking agent (Xusal®): 1 point per tablet ·Nasal steroid (Nasonex®): 2 points per daily dose * ·Oral Steroids (Decortin® 50 mg): 3 points per tablet ** ·Asthma [...] for more please refer to protocol ;Primary end point(s): The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized against grass pollen. Primary criterion Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season) | — |
Countries
Germany
Outcome results
None listed