| Autor: |
S. Zielen, P. Kuna, W. Aberer, S. Lassmann, O. Pfaar, L. Klimek, A. Wade, K. Kluehr, J. Raab, D. Wessiepe, D. Lee, M.F. Kramer, K. Gunawardena, T. Higenbottam, M.D. Heath, M.A. Skinner, P.J. de Kam |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
|
| Zdroj: |
World Allergy Organization Journal, Vol 12, Iss 11, Pp - (2019) |
| Druh dokumentu: |
article |
| ISSN: |
1939-4551 |
| DOI: |
10.1016/j.waojou.2019.100075 |
| Popis: |
Background: Pollinex Quattro Grass (PQ Grass) is an effective, well-tolerated, short pre-seasonal subcutaneous immunotherapy to treat seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen. In this Phase II study, 4 cumulative doses of PQ Grass and placebo were evaluated to determine its optimal cumulative dose. Methods: Patients with grass pollen-induced SAR were randomised to either a cumulative dose of PQ Grass (5100, 14400, 27600 and 35600 SU) or placebo, administered as 6 weekly subcutaneous injections over 31–41 days (EudraCT number 2017-000333-31). Standardized conjunctival provocation tests (CPT) using grass pollen allergen extract were performed at screening, baseline and post-treatment to determine the total symptom score (TSS) assessed approximately 4 weeks after dosing. Three models were pre-defined (Emax, logistic, and linear in log-dose model) to evaluate a dose response relationship. Results: In total, 95.5% of the 447 randomized patients received all 6 injections. A highly statistically significant (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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