Rhinoconjunctivitis, Allergic Asthma
Conditions
Keywords
specific immunotherapy, SIT
Brief summary
To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.
Interventions
DRUGGrass pollen specific immunotherapy
* Strength 1 (0.78μg/mL) * Strength 2 (6.25μg/mL) * Strength 3 (50μg/mL) * Strength 4 (200μg/mL) The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo.
DRUGPlacabo
Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.
Sponsors
Allergopharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Has the subject given informed consent according to local requirements before any trial-related activities? 2. Is the subject a legally competent male or female outpatient? 3. Is the subject aged 12 - 65 year? 4. Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by * skin prick test wheal for grass pollen ≥ 5mm in diameter and * histamine (1,0% histamindihydrochloride ) wheal ≥ 3mm and * NaCl control reaction \< 3mm and * EAST result (inhouse Allergopharma) ≥ 1.5kU/L to grass pollens and * proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and * main discomfort in the respective months. * Does the subject with bronchial asthma at entry have a confirmed diagnosis of asthma and does his asthma has been classified as controlled according to GINA guidelines (version 2006) with PEF or FEV1at least 80% of predicted normal? 5. Has the subject been treated with anti-allergic medications for at least 2 years prior to enrolment? (Subjects with perennial and continuously treated asthma have to be excluded, see
Exclusion criteria
below.) 6. For female patients: Does the subject use effective contraception and does she have a negative pregnancy test result? (Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations.) 7. Does the subject suffer from rhinoconjunctivitis symptoms documented in the subjects diary during the baseline season? 8. Does the subject have demonstrated a symptom-score of at least 4 per day during the week following the peak pollen count in the baseline season?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rhinoconjunctivitis Symptom-Medication-Score | 2 years | Change of the AUC of the RC-SMS from the baseline season to the season after 2 years of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | entire trial | Safety of treatment during the entire trial period will be assessed by clinical laboratory, vital signs and adverse events displayed by MedDRA SOC and Preferred Term. |
Countries
Germany
Outcome results
None listed