Allergic rhinitis and/or rhinoconjunctivitis with or without mild intermitent asthma caused by clinical relevant sensitization against grass pollen. MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Product Name: Depigoid Gräser-Mix
Pharmaceutical Form: Solution for injection
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the place
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 = 18 years old 3. History of clinical relevant allergic rhinitis and/or rhinoconjunctivitis to grass pollen and a positive skin prick test for Dactylis glomerata pollen at or within 12 months prior to the screening visit 4. Symptoms more than 2 years prior to study start 5. Subject must exhibit a moderate response upon 4000 Dactylis glomerata pollen grains/m3 within 2 hours in the Environmental Challenge Chamber at visit 4 and at the baseline visit (V6) which is defined as to have at least 30% of the maximum possible TNSS score (i.e. 120) of at least 1 of 4 records during the pollen exposure 6. FEV1/FVC = 70% predicted 7. Absence of any structural nasal abnormalities or nasal polyps, absence of a history of frequent nose bleeding or recent nasal surgery 8. Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer EEC for 2 hours 9. Non smokers or smokers with a history of less than 10 pack years 10. Able and willing to give written informed consent to take part in the study 11. Available to complete all study measurements 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 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 sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite) 2. Persistent asthma (GINA = II) 3. Intermittent asthma having been treated with steroids within 2 years prior to screening 4. History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening and during the study 5. Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures Patients with other known previous / concomitant diseases 6. Active tuberculosis 7. Acute and chronic inflammatory or infectious diseases at the target organ (not including intermittent asthma, rhinitis and rhinoconjunctivities) 8. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis) 9. Autoimmune disorders (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) 10. Immune deficiencies 11. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism) 12. 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 13. Malignant disease of any kind during the previous 5 years 14. Abnormal laboratory parameters and vital signs that could increase the risk to the study participant 15. Alcohol, drug or medication abuse within the past year 16. Severe psychiatric / psychological or 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: 17. SIT with grass pollen extract within the last 5 years 18. 7 days prior and 14 days post an immunization with vaccines 19. Anti-allergic treatment within the last 4 weeks prior to screening, apart from rescue medication (i.e. nasal/ocular H1-blocking agents and Salbutamol) right after each pollen chamber visit and rescue medication for the use during the grass pollen season for symptoms of grass pollen allergic rhinitis and/or rhinoconjunctivitis and/or asthma (i.e. Systemic and topical antihistaminic and Salbutamol) 20. Locally and systemically treatment with ß-blocker is not allowed during the entire study and will lead to the patient being withdrawn 21. Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn 22. Treatment with tranquillizer or psychoactive drugs. Others 23. Patients who are expected to be non-compliant and/or not cooperative 24. Participation in the treatment phase of any other clinical study within the last 30 days prior to the start of the study 25. Patients who have already participated in this study 26. Patients who are employees at the investigational site, relatives or spouses of the investigator 27. Any donation of germ cells, blood, organs, or bone marrow during the course of the study 28. Patients who are not contractually capable Special restrictions for female patients 29. Pregnant or nursing (lactating) women, where pregnancy is defin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the comparison of the efficacy and safety of Depigoid® Grass Mix versus placebo starting with the pre-seasonal immunotherapy under stan-dardized pollen chamber conditions and proceeding with the grass pollen season immunotherapy over the following grass pollen season in patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma caused by clinical rele-vant sensitization against grass pollen. ;Secondary Objective: ·Single symptoms of TNSS during Environmental Challenge Chamber ·TNSS at Visit 20 ·Symptom items as assessed by the patient questionnaire ·Difference of the distributed weight and the collected weight of paper tissues ·Use of rescue medication during pollen season as assessed by the patient diary (leaving out the time window of ±3 days around the last pollen chamber visit) ·Single symptoms of TNSS during pollen season as assessed by the patient diary (leaving out the time window of ±3 days around the last pollen chamber visit) ·Laboratory ·Adverse events ·Global evaluation of safety ;Primary end point(s): Mean Total Nasal Symptom Score (TNSS) at visit V14 for the symptoms nasal obstruction, rhinorrhea, nasal itching and sneezing, each scored on a 100 mm visual analogue scale (VAS) ranging from ‘none’ to ‘severe’. | — |
Countries
Germany
Outcome results
None listed