An Exploratory Study of PQ Grass 27600 SU (NCT04687059) | Clinical Trial Compass
CompletedPhase 2/3
An Exploratory Study of PQ Grass 27600 SU
United States119 participantsStarted 2020-10-19
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Capable of giving signed informed consent and demonstrates willingness to comply with the requirements and restrictions listed in the ICF and study protocol and to attend required study visits.
✓. Subject who has signed and dated the ICF.
✓. 18 to 65 years of age inclusive, at the time of signing the ICF.
✓. Male or female.
✓. Female subjects who are not of childbearing potential (defined as at least 12 months natural spontaneous amenorrhoea, or at least 6 weeks following surgical menopause) or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol.
✓. Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination, and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
✓. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal corticosteroids, and/or leukotriene modifiers for relief of symptoms during the last 2 consecutive seasons prior to the study, confirmed by subject records.
✓. A positive SPT for grass pollen (wheals \[longest diameter\] ≥3 mm and histamine ≥3 mm) and a negative SPT to the negative control (wheal diameter =0) at screening.
Exclusion criteria
What they're measuring
1
CSMS (Combined Symptom and Medication Score) Averaged Over the Peak Grass Pollen Season (GPS)
Timeframe: Measures collected approximately over 2-5 weeks (peak GPS). The exact time frame depended on the GPS start and end dates for each region (depending on pollen detection), therefore, a specific week from baseline can not be estimated globally.
✕. Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass) as verified by medical history and positive SPT.
✕. Subjects with a positive SPT at US and EU sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
✕. Moderate to severe symptoms during the 3 years prior to Visit 1 to another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and /or impact the data collected, as determined by the investigator.
✕. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
✕. History of autoimmune disease including Hashimoto's thyroiditis or other immunological disorder or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
✕. Presence of severe or uncontrolled or partly controlled asthma as defined in the GINA guidelines (GINA 2020) or asthma that requires more than a daily dose above 400 mcg of inhaled budesonide or equivalent.
✕. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening and randomisation or any history of a life-threatening asthma attack.