PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU cumulative dose on symptom and medication score in a field setting. The study will enrol adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure.
PQGrass309 is a randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by grass pollen exposure. The study is expected to be conducted in the United States (US) and the European Union (EU). The study will enrol enough subjects to allow treatment of approximately 150 subjects. The aim of this exploratory field study is to explore amongst others the following: * The efficacy and safety (up to 6 months following treatment) of a cumulative dose of 27600 standardised units (SU) of PQ Grass in the treatment of grass pollen allergy. * The expected average treatment effect on combined symptom and medication score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
Suspension for injection
Suspension for injection
Solution for injection
Allergy and Asthma Associates of Bluegrass
Lexington, Kentucky, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Atlantic Research Center, LLC
CSMS (Combined symptom and medication score) averaged over the peak grass pollen season (GPS)
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms
Time frame: Approximately 2-5 weeks
CSMS averaged over the entire (or truncated) GPS
6 individual symptoms assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time frame: Approximately 10 weeks
Total combined score (TCS) averaged over the peak GPS
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time frame: Approximately 2-5 weeks
TCS averaged over entire (or truncated) GPS
6 individual symptoms in a similar fashion to CSMS assessed in a 4 point severity scale (0-No symptoms to 3-Severe symptoms)
Time frame: Approximately 10 weeks
Daily symptom score (dSS) of the CSMS averaged over the peak and entire (or truncated) GPS
Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms assessed in CSMS divided by 6
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Daily medication score (dMS) of the CSMS averaged over the peak and entire (or truncated) GPS
Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ocean Township, New Jersey, United States
Smith Allergy & Asthma Specialists
Cortland, New York, United States
Corning Center for Clinical Research
Horseheads, New York, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Universitatsmedizin Berlin - Charite Campus Mitte - Allergie Centrum Charite
Berlin, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
...and 4 more locations
dSS of the TCS averaged over the peak GPS and entire (or truncated) GPS
Sum of the scores (0-No symptoms to 3-Severe symptoms) for the 6 individual symptoms (i.e. ranging from 0 to 18)
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
dMS of the TCS averaged over the peak GPS and entire (or truncated) GPS
Score 0 (no relief medication) to 3 (highest step relief medication) per day; based on at least 1 dose of the medication of the highest step taken that day
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
TSS during CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the peak and entire (or truncated) GPS for subjects with a positive CPT at baseline.
CPT - Conjunctival provocation test - At screening, during randomization and pre-GPS
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
The probability of well days and severe days during the peak and entire (or truncated) GPS.
Time frame: Approximately 10 weeks. Duration of the Peak Grass pollen season (GPS) to be determined as per pollen counts within the GPS
Pre-GPS (Visit 12) TSS measured during CPT
Pre-season
Time frame: Assessment Baseline (pre-GPS)
Serum Ig responses (total IgE; grass-specific IgE and IgG4; specific IgE/total IgE and specific IgE/specific IgG4) at Visit 12 and Visit 15.
Time frame: Approximately 10 weeks
RQLQ(S) measured within the GPS
Rhinoconjunctivitis quality of life questionnaire with standardised activities - RQLQ(S)
Time frame: Approximately 10 weeks
Frequency, severity and relationship of AEs to treatment
AEs - Adverse Events
Time frame: Up to 1 year
Frequency of AEs leading to premature discontinuation from treatment or study
Time frame: Up to 1 year
Frequency of AESI
AESI - Adverse events of special interest
Time frame: Up to 1 year
Changes in serum chemistry values between screening and Visit 15
Including sodium, potassium and chloride concentration
Time frame: 6 months approximately
Changes in serum chemistry values between screening and Visit 15
Including Glucose, uric acid, urea, calcium, creatinine, total protein, phosphorus, cholesterol, albumin and total bilirubin concentration
Time frame: 6 months approximately
Changes in serum chemistry values between screening and Visit 15
Including alkaline phosphatase, LDH, AST, ALT, GGT, CRP.
Time frame: 6 months approximately
Changes in haematology values between screening and Visit 15 - RBC, WBC, Platelets
Including total WBC and differentials, total RBC, RBC indices and platelet count.
Time frame: 6 months approximately
Changes in haematology values between screening and Visit 15 - Haemoglobin
Haemoglobin concentration
Time frame: 6 months approximately
Changes in clinical laboratory values (urinalysis) between screening and Visit 15
Urinalysis (using a urine dip-stick) pH, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen, leukocytes. Note: Microscopic examination will be conducted if protein, leukocytes, nitrite, and/or blood are detected. If needed, microscopic examination will include WBC, RBC, casts, and bacteria.
Time frame: 6 months approximately
Changes in vital signs (all subjects) at all treatment visits - Blood pressure
systolic and diastolic blood pressure
Time frame: 7 months approximately
Changes in vital signs (all subjects) at all treatment visits - Pulse rate
Time frame: 7 months approximately
Changes in vital signs (all subjects) at all treatment visits - Respiratory rate
Time frame: 7 months approximately
Changes in vital signs (all subjects) at all treatment visits - Body temperature
Time frame: 7 months approximately
Changes in PEFR (only in subjects with past or current asthma) at all treatment visits
PEFR - peak expiratory flow rate
Time frame: 7 months approximately