A long-term, double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of PQ Grass 27600 SU in children and adolescents with seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure

Seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure

-Part A: The CSMS averaged over the peak GPS during Year 1., -Part B: The CSMS averaged over the peak GPS after 2 years of treatment-free follow-up.

Part A Efficacy: - The CSMS averaged over the entire (or truncated) GPS. - The dSS component of the CSMS averaged over the peak GPS. - The dMS component of the CSMS averaged over the peak GPS., - The TCS averaged over the peak GPS. - The probability of well days and severe days during the peak GPS. - Serum grass specific IgG4 at Visit 11 compared to Part A Visit 1 (baseline). - Change from Part A Visit 2 (baseline) to Visit 11 in PRQLQ, AdolRQLQ and RQLQ(S) measured in selected countries., Part A Safety: - Frequency, severity and relationship of AEs to treatment. - Frequency of AEs leading to premature discontinuation from treatment or trial. - Frequency of AESI., - Changes in clinical laboratory values (serum chemistry, haematology, urinalysis) between screening and Visit 11. - Changes in vital signs (all subjects) and spirometry/PEFR (only in subjects with past or current asthma) at all treatment visits., Part B Efficacy: Key secondary endpoints: - The CSMS averaged over the peak GPS after 3 years of treatment. - The TCS averaged over the peak GPS after 3 years of treatment. - The TCS averaged over the peak GPS after 2 years of treatment-free follow-up., - The CSMS averaged over the entire (or truncated) GPS after 3 years of treatment. - The dSS component of the CSMS averaged over the peak GPS after 2 years of treatment-free follow-up. - The dMS component of the CSMS averaged over the peak GPS after 2 years of treatment-free follow-up. - Serum grass specific IgG4 after 3 years of treatment compared to Part B Visit 1 (baseline)., Part B Efficacy: Other secondary endpoints: - The CSMS averaged over the peak GPS after 1 and 2 years of treatment and 1 year of treatment-free follow-up. - The CSMS averaged over the entire (or truncated) GPS after 1 and 2 years of treatment and 1 and 2 years of treatment-free follow-up. - The TCS averaged over the peak GPS after 1 and 2 years of treatment and 1 year of treatment-free follow-up., - The dSS component of the CSMS averaged over the peak GPS after 1, 2 and 3 years of treatment and 1 and 2 years of treatment-free follow-up. - The dMS component of the CSMS averaged over the peak GPS after 1, 2 and 3 years of treatment and 1 and 2 years of treatment-free follow-up. - The probability of well days and severe days during the peak GPS after 1, 2 and 3 years of treatment and 1 and 2 years of treatment-free follow-up., - Serum grass specific IgG4 after 1 and 2 years of treatment compared to Part B Visit 1 (baseline). - Changes from Part B Visit 2 (baseline) in RQLQ(S), PRQLQ and AdolRQLQ measured in selected countries, after 1, 2 and 3 years of treatment and 1 and 2 years of treatment-free follow-up., Part B Safety: - Frequency, severity and relationship of AEs to treatment. - Frequency of AEs leading to premature discontinuation from treatment or trial. - Frequency of AESI., - Changes in clinical laboratory values (serum chemistry, haematology, urinalysis). - Changes in vital signs (all subjects) and spirometry/PEFR (only in subjects with past or current asthma) at all treatment visits.

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