E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent asthma caused by clinical relevant sensitization against grass pollen. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039083 |
E.1.2 | Term | Rhinitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
·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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 3 and a score < 2 for each single symptom, i.e. obstruction, rhinorrhea, itch, and sneeze prior to the screening allergen challenge 7. FEV1 ≥ 80% predicted and FEV1/FVC ≥ 70% predicted at screening 8. Absence of any structural nasal abnormalities or nasal polyps, absence of a history of frequent nose bleeding or recent nasal surgery 9. Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer EEC for 4 hours 10. Non smokers or smokers with a history of less than 10 pack years 11. Able and willing to give written informed consent to take part in the study 12. Available to complete all study measurements
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E.4 | Principal 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 hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |