ICD classification code: J 45.0 and J 30.1 MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10039087 Term: Rhinitis allergic NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Allergoid preparation Phleum pratense
Product Code: Allergoid Phleum
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Allergoid Phleum Pratense
Concentration unit: PNU
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 and any other trial-related activity performed with trial specific diagnostics or with trial medication) 2. Is the patient a legally competent male or female outpatient, aged 18 – 65 years? 3. Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by a) skin prick test (SPT) wheal for Timothy grass pollen and 6-grasses mixture = 3mm in diameter and b) histamine (0.1% histamine) wheal = 3mm in diameter and c) a negative NaCl control reaction =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For female subjects: 1. a positive pregnancy test at screening. 2. use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator. 3. Known Pregnancy or lactation period. 4. seeking to become pregnant during study duration. General criteria: 5. weighing less than 40kg. 6. Unable to understand and comply with the requirements of the trial, as judged by the investigator. 7. Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days. 8. Involvement in the planning and conduct of the trial. 9. Allergopharma Joachim Ganzer KG staff or staff at the trial sites. 10. any relationship of dependence with the sponsor and/or with the investigator. 11. Mentally disabled patients 12. Institutionalised due to an official or judicial order. Immunotherapy criteria: 13. Previous specific immunotherapy with grass pollen in any formulation. 14. Any current immunotherapy. 15. Any previous specific immunotherapy with unknown allergen or an unsuccessful immunotherapy. Other allergies: 16. A skin prick test or RAST result to the other tested allergens with > Timothy grass pollen allergens and/or 6-grasses pollen allergen mixture. • Sensitisation to dog epithelia (skin prick test > Timothy grass pollen allergens and/or 6-grasses pollen allergen mixture) is acceptable, if the patient has no direct contact to dogs and / or • Sensitisation to cat epithelia (RAST = 0.70kU/L) epithelia is acceptable, if the patient has no direct contact to cats. Diseases and health status: 17. Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons (e.g. vasomotor or rhinitis medicamentosa). 18. PEF < 80% (GINA grade III or IV) of predicted normal (ECSC). 19. Uncontrolled or partly controlled asthma according to GINA guidelines (version 2006). 20. Perennial and continuously treated asthma. 21. Rhinoconjunctival atopic symptoms for 20 years or longer. 22. Severe acute or chronic diseases that would affect the study objectives or patient safety (e.g., Diabetes mellitus type I, malignant neoplasia, chronic renal failure), coronary heart diseases, severe inflammatory diseases (e.g. liver, kidneys). 23. Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, multiple sclerosis (MS), active tuberculosis, lupus erythematodes [SLE], Grave’s disease, Hashimoto’s thyroiditis) at time of screening. 24. Any clinically significant (as determined by the investigator) psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse). 25. Recurrent seizures. 26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiestasis). 27. For patients consent for the visit in the environmental challenge chamber (ECC): An anatomic abnormality that interferes with assessment of Total Nasal Symptom- -Score (TNSS). 28. Atopic dermatitis or other dermatological abnormalities (e.g. Naevi, tattoos, scars, etc.) contraindicating intracutaneous testing. 29. A negative reaction of the positive control after 15 minutes in the pre-treatment ICT. 30. A local swelling area of the fore arm beyond the wrist and elbow as result of the LPR of the ICT with the lower of the two applied doses on visit S2. 31. Laboratory values beyond Grade 1 according to the FDA Guidance for Industry (Toxici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the dose response relationship regarding efficacy and safety of an allergoid preparation of Phleum pratense in adult patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without bronchial asthma.;Secondary Objective: 1) To investigate the efficacy and tolerability of a 6-grasses pollen allergen mixture in adult patients with IgE mediated allergic rhinitis 2)To compare the efficacy and safety of the regular up-dosing regimen of the allergoid preparation of Phleum pratense, the 6-grasses mixture and the shortened up-dosing regimen of Phleum pratense. ;Primary end point(s): The change of the size of the swelling (area in mm²) 6 hours after intracutaneous testing (Late Phase Reaction) between baseline (visit S2) and after treatment (visit FU2). Therefore, the size of the swelling area measured after application of the individual optimal concentration (determined during visit S2) will be subtracted.;Timepoint(s) of evaluation of this end point: post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Change of the Total Nasal Symptom Score (TNSS) as measured in the ECC between baseline and after end of treatment. • Change from baseline in specific total IgG and IgG4 and at the end of treatment. • Change of the amount of nasal secretion in the ECC between baseline and after end of treatment. Safety Safety of treatment during the entire trial period will be assessed by • Adverse events (AE) overall and systemic AEs. • Size of local reactions (diameter in mm) at the injection site 30min after drug administration. • Clinical laboratory tests (hematology, clinical chemistry and urinalysis). • Vital signs (resting blood pressure, pulse rate and respiratory rate). ;Timepoint(s) of evaluation of this end point: post-treatment | — |
Countries
Germany
Outcome results
None listed