Allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent asthma caused by clinical relevant sensitization against grass pollen. MedDRA version: 8.1 Level: LLT Classification code 10039083 Term: Rhinitis
Conditions
Interventions
Trade Name: Depigoid Grass Mix
Product Name: Depigoid Grass Mix
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: Freeze-dried depigmented and gl
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 allergic rhinitis 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 the screening visit, which is defined as a Total Nasal Symptom Score (TNSS) of at least 6 on at least one of eight evaluation records during the pollen exposure 6. Total Nasal Symptom Score (TNSS) of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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.History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening and during the study 4.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 5.Active tuberculosis 6.Acute and chronic inflammatory or infectious diseases at the target organ (not including asthma) 7.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis) 8.Autoimmune disorders (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) 9.Immune deficiencies 10.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism) 11.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 12.Malignant disease of any kind during the previous 5 years 13.Abnormal laboratory parameters and vital signs that could increase the risk to the study participant 14.Alcohol, drug or medication abuse within the past year 15.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: 16. SIT within the last 5 years 17. 7 days prior and 14 days post an immunization with vaccines 18. Anti-allergic treatment within the last 4 weeks prior to screening 19. beta-blocker are not allowed during the entire study and will lead to the patient being withdrawn 20. Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn Others 21. Patients who are expected to be non-compliant and/or not cooperative 22. Participation in the treatment phase of any other clinical study within the last 30 days prior to the start of the study 23. Patients who have already participated in this study 24. Patients who are employees at the investigational site, relatives or spouses of the investigator 25. Any donation of germ cells, blood, organs, or bone marrow during the course of the study 26. Patients who are not contractually capable Special restrictions for female patients 27. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation. 28. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hyste
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the investigation of the safety and efficacy of a presea-sonal, 5 weeks rush treatment scheme with Depigoid® Grass Mix in patients with al-lergic rhinitis sensitized to grass pollen under standardized pollen chamber condi-tions. Primary criterion Change from baseline in the mean of the “Total Nasal Symptom Score” during the last two hours of allergen challenge for the symptoms rhinorrhea, nasal congestion, sneezing and nasal itching on a scale from 0-3 (none - severe) for each one. ;Secondary Objective: ·Change from baseline in the mean of the weight of paper tissues during four hours of allergen challenge ·Change from baseline in the mean nasal flow measured by anterior rhinomanome-try during four hours of allergen challenge ·Adverse events ·Global evaluation of safety ;Primary end point(s): Change from baseline in the mean of the “Total Nasal Symptom Score” during the last two hours of allergen challenge for the symptoms rhinorrhea, nasal congestion, sneezing and nasal itching on a scale from 0-3 (none - severe) for each one. | — |
Countries
Germany
Outcome results
None listed