Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
NCT ID: NCT05540717
Last Updated: 2025-04-02
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
555 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-11
Study Completion Date
2023-11-01
Brief Summary
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The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ Grass.
The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).
The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).
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Detailed Description
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Multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to confirm the efficacy and safety of the optimal effective dose of PQ Grass (27600 SU).
Randomized study subjects, in a randomisation ratio of 1:1, will receive either treatment with 6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU, or 6 injections of placebo prior to the onset of the grass pollen season (GPS).
The aim of the study is to confirm the efficacy and safety of the optimal effective dose of the PQ Grass 27600 SU dose. Efficacy will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak GPS.
Randomized study subjects, in a randomisation ratio of 1:1, will receive either treatment with 6 injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU, or 6 injections of placebo prior to the onset of the grass pollen season (GPS).
The aim of the study is to confirm the efficacy and safety of the optimal effective dose of the PQ Grass 27600 SU dose. Efficacy will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak GPS.
Conditions
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Seasonal Allergic Rhinitis
Rhinoconjunctivitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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PQ Grass
6 subcutaneous injections of active treatment (900, 2700, 6000, 6000, 6000 and 6000 SU sequentially) to achieve a cumulative nominal dose of 27600 SU
Group Type
EXPERIMENTAL
PQ Grass
Intervention Type
BIOLOGICAL
Suspension for Injection
Placebo
6 subcutaneous injections of placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
BIOLOGICAL
Solution for injection
Interventions
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PQ Grass
Suspension for Injection
Intervention Type
BIOLOGICAL
Placebo
Solution for injection
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF (informed consent form) and in this clinical trial protocol and to attend required clinical trial visits.
2. Subject who has a signed and dated ICF.
3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. 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/permanent sterilisation \[hysterectomy, bilateral oophorectomy and bilateral salpingectomy\]) or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol.
6. Good general health, as determined by the Investigator, based on a medical evaluation, including medical history, physical examination, mental status assessment 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 clinical trial procedures.
7. Positive history of moderate to severe symptoms of SAR/rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure of at least 2 seasons duration, despite having received allergy pharmacotherapy (e.g., antihistamines, nasal corticosteroids, leukotriene modifiers, etc.) during the last 2 consecutive grass pollen seasons prior to the clinical trial, confirmed by subject records.
Please note: Subjects with asthma may be included, but the asthma must be well controlled (according to current Global Initiative for Asthma \[GINA\] guidelines \[GINA 2022\]).
8. A positive SPT (skin prick test) to histamine (wheals \[longest diameter\] ≥3 mm) and a negative SPT to the negative control (wheal diameter = 0 mm) at screening.
9. A positive SPT for grass pollen (wheals \[longest diameter\] ≥3 mm).
10. Grass specific IgE (immunoglobulin E) class ≥2 as documented by an ImmunoCAP test at screening.
11. Forced expiratory volume in one second (FEV1) ≥70% of predicted, with a FEV1/forced vital capacity (FVC) ratio \>75% and PEFR (peak expiratory flow rate) ≥70% of predicted at screening.
2. Subject who has a signed and dated ICF.
3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. 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/permanent sterilisation \[hysterectomy, bilateral oophorectomy and bilateral salpingectomy\]) or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol.
6. Good general health, as determined by the Investigator, based on a medical evaluation, including medical history, physical examination, mental status assessment 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 clinical trial procedures.
7. Positive history of moderate to severe symptoms of SAR/rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure of at least 2 seasons duration, despite having received allergy pharmacotherapy (e.g., antihistamines, nasal corticosteroids, leukotriene modifiers, etc.) during the last 2 consecutive grass pollen seasons prior to the clinical trial, confirmed by subject records.
Please note: Subjects with asthma may be included, but the asthma must be well controlled (according to current Global Initiative for Asthma \[GINA\] guidelines \[GINA 2022\]).
8. A positive SPT (skin prick test) to histamine (wheals \[longest diameter\] ≥3 mm) and a negative SPT to the negative control (wheal diameter = 0 mm) at screening.
9. A positive SPT for grass pollen (wheals \[longest diameter\] ≥3 mm).
10. Grass specific IgE (immunoglobulin E) class ≥2 as documented by an ImmunoCAP test at screening.
11. Forced expiratory volume in one second (FEV1) ≥70% of predicted, with a FEV1/forced vital capacity (FVC) ratio \>75% and PEFR (peak expiratory flow rate) ≥70% of predicted at screening.
Exclusion Criteria
1. Pregnant or lactating subject.
2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT at screening or positive specific IgE \[≥2\] at screening) to any other seasonal allergen (other than grass) or perennial allergens.
Exception: Period 1, Period 2 and Period 3 of the entire clinical trial will be conducted outside of the pollen season(s) of concern or perennial allergies are irrelevant due to avoidance measures (e.g., cats and dog allergy). Subjects with mild allergy symptoms (only) to any other allergen apart from grass may be included at the discretion of the Investigator. In countries in Europe where Bermuda grass is present, any medical history of moderate to severe allergy symptoms to Bermuda grass (verified by a positive SPT or positive specific IgE \[Class ≥2\]), will also represent a reason for exclusion as it will not be possible to conduct Period 1, Period 2 and Period 3 of the entire clinical trial outside of Bermuda grass pollen season. Albeit Bermuda grass being commonly defined as a grass, it belongs to the Poaceae family, while the sentence (other than grass) in Exclusion criterion #2 refers to grass of Pooideae subfamily (as defined in Inclusion criterion #7).
3. Subjects at US clinical trial sites in regions where southern grasses (Bahia grass, Bermuda grass or Johnson grass) are the dominant grasses and the main cause of grass allergy symptoms with a positive SPT to any of the 3 grasses (irrespective of the severity of symptoms).
4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the SPT done at screening that cannot be avoided during the Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
8. History of any other immunological disorder or other diseases (including, but not limited cardiovascular \[including uncontrolled or inadequately controlled hypertension\], gastro-intestinal, hepatic, renal, haematological, 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 clinical trial treatment.
9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
1. Severe asthma (as per the current GINA guidelines \[GINA, 2022\]).
2. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2022).
3. Asthma that requires more than a daily dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroid) as per the current GINA guidelines (GINA, 2022).
4. History of 2 or more systemic corticosteroid courses within 6 months of screening or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening or Visit 2 to treat asthma.
5. Prior intubation/mechanical ventilation for asthma.
6. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
7. Any history of a life-threatening asthma attack.
8. FEV1 \<70% of predicted or FEV1/FVC ≤75% or PEFR \<70% of predicted with or without controller medications at screening or Visit 2.
10. Presence non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
11. Presence of nasal polyps and/or chronic sinusitis.
12. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
13. Eye surgery within the past 6 months.
14. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
15. Clinical history of Type I diabetes or poorly controlled Type II diabetes.
16. Moderate to severe upper or lower respiratory infections requiring medication within 14 days before screening (Visit 1) or Visit 2.
17. Presence of acute or chronic infection, fever or inflammation at screening or Visit 2.
18. Clinical history of severe systemic reaction or serious systemic reaction in response to AIT (allergen immunotherapy) in the past.
19. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
20. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the investigational drug/placebo.
21. Clinical history of allergy, hypersensitivity or intolerance to the relief medications (for relief of allergy symptoms during Period 3) provided for use in this clinical trial.
22. Clinical history of hereditary angioedema.
23. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac arrhythmias, closed angle glaucoma or subjects taking other sympathomimetics).
24. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
25. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
26. Subjects who have suspicion or symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (as assessed by the Investigator) or who have had unprotected contact with a confirmed case of COVID-19 (coronavirus disease 2019) in the 2 weeks prior to screening or Visit 2 (based on the Investigator's discretion).
27. Subjects who were hospitalised for COVID-19 within 6 months prior to screening or Visit 2.
28. Any history of AIT for grass pollen allergy in the past or history of AIT for any other type of allergy (excluding food allergy) in the past 5 years.
29. Inability to adhere to the washout periods listed in the protocol, with respect to screening and to refrain from using the medications indicated until after Visit 11.
30. Treatment with a preparation containing MPL (monophosphoryl lipid-A) (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 11 (with the exception of the investigational drug).
31. Previous history of epinephrine auto-injector use.
32. β-blocker medication (local or systemic, including eye drops) for any indication.
33. Monoamine oxidase inhibitors and tricyclic antidepressants. Please note: Tricyclic antidepressants should be avoided at least 2 weeks prior to screening.
34. Any previous therapy (within the previous 5 years) or current therapy with anti IgE (e.g., omalizumab \[Xolair\]) or anti-interleukins (e.g., mepolizumab).
35. Current or past therapy (within the previous 5 years) with any other immunomodulatory biologics.
36. Unable to refrain from any vaccination (including influenza vaccine and COVID-19 vaccine) during the clinical trial (unless administered \>30 days prior to randomisation).
Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time. Booster vaccinations (only) for COVID-19 can be administered during the clinical trial apart from during the treatment period. There should be at least 14 days interval from the last administration of the investigational drug/placebo prior to administration of a COVID-19 booster injection.
37. Participation in a clinical research trial with any investigational drug within 4 weeks of Visit 1 or concomitantly with this clinical trial.
Please note: The period of exclusion begins at the time of the last visit of the prior clinical research trial. Subjects consented and screened, but not dosed in the prior clinical research trial are not excluded.
38. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
39. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
40. Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as:
* Absence of a total of 22 days or more in similar geographical regions (as determined by the Investigator), with no single trip in a similar geographical region exceeding 14 days.
* Absence of a total of 15 days or more in non-similar geographic regions (as determined by the Investigator), with no single trip in a non-similar geographical region exceeding 7 days.
41. Have changed residence to a different geographical region(s) since the last GPS.
Exception: The old and new residences are in the same or similar geographical region as determined by the Investigator.
2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT at screening or positive specific IgE \[≥2\] at screening) to any other seasonal allergen (other than grass) or perennial allergens.
Exception: Period 1, Period 2 and Period 3 of the entire clinical trial will be conducted outside of the pollen season(s) of concern or perennial allergies are irrelevant due to avoidance measures (e.g., cats and dog allergy). Subjects with mild allergy symptoms (only) to any other allergen apart from grass may be included at the discretion of the Investigator. In countries in Europe where Bermuda grass is present, any medical history of moderate to severe allergy symptoms to Bermuda grass (verified by a positive SPT or positive specific IgE \[Class ≥2\]), will also represent a reason for exclusion as it will not be possible to conduct Period 1, Period 2 and Period 3 of the entire clinical trial outside of Bermuda grass pollen season. Albeit Bermuda grass being commonly defined as a grass, it belongs to the Poaceae family, while the sentence (other than grass) in Exclusion criterion #2 refers to grass of Pooideae subfamily (as defined in Inclusion criterion #7).
3. Subjects at US clinical trial sites in regions where southern grasses (Bahia grass, Bermuda grass or Johnson grass) are the dominant grasses and the main cause of grass allergy symptoms with a positive SPT to any of the 3 grasses (irrespective of the severity of symptoms).
4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the SPT done at screening that cannot be avoided during the Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
8. History of any other immunological disorder or other diseases (including, but not limited cardiovascular \[including uncontrolled or inadequately controlled hypertension\], gastro-intestinal, hepatic, renal, haematological, 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 clinical trial treatment.
9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
1. Severe asthma (as per the current GINA guidelines \[GINA, 2022\]).
2. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2022).
3. Asthma that requires more than a daily dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroid) as per the current GINA guidelines (GINA, 2022).
4. History of 2 or more systemic corticosteroid courses within 6 months of screening or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening or Visit 2 to treat asthma.
5. Prior intubation/mechanical ventilation for asthma.
6. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
7. Any history of a life-threatening asthma attack.
8. FEV1 \<70% of predicted or FEV1/FVC ≤75% or PEFR \<70% of predicted with or without controller medications at screening or Visit 2.
10. Presence non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
11. Presence of nasal polyps and/or chronic sinusitis.
12. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
13. Eye surgery within the past 6 months.
14. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
15. Clinical history of Type I diabetes or poorly controlled Type II diabetes.
16. Moderate to severe upper or lower respiratory infections requiring medication within 14 days before screening (Visit 1) or Visit 2.
17. Presence of acute or chronic infection, fever or inflammation at screening or Visit 2.
18. Clinical history of severe systemic reaction or serious systemic reaction in response to AIT (allergen immunotherapy) in the past.
19. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
20. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the investigational drug/placebo.
21. Clinical history of allergy, hypersensitivity or intolerance to the relief medications (for relief of allergy symptoms during Period 3) provided for use in this clinical trial.
22. Clinical history of hereditary angioedema.
23. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated such as in subjects with hyperthyroidism, uncontrolled hypertension, cardiac arrhythmias, closed angle glaucoma or subjects taking other sympathomimetics).
24. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
25. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
26. Subjects who have suspicion or symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (as assessed by the Investigator) or who have had unprotected contact with a confirmed case of COVID-19 (coronavirus disease 2019) in the 2 weeks prior to screening or Visit 2 (based on the Investigator's discretion).
27. Subjects who were hospitalised for COVID-19 within 6 months prior to screening or Visit 2.
28. Any history of AIT for grass pollen allergy in the past or history of AIT for any other type of allergy (excluding food allergy) in the past 5 years.
29. Inability to adhere to the washout periods listed in the protocol, with respect to screening and to refrain from using the medications indicated until after Visit 11.
30. Treatment with a preparation containing MPL (monophosphoryl lipid-A) (e.g., Cervarix, Shingrix, Fendrix) within 2 years prior to Visit 1 and until after completion of Visit 11 (with the exception of the investigational drug).
31. Previous history of epinephrine auto-injector use.
32. β-blocker medication (local or systemic, including eye drops) for any indication.
33. Monoamine oxidase inhibitors and tricyclic antidepressants. Please note: Tricyclic antidepressants should be avoided at least 2 weeks prior to screening.
34. Any previous therapy (within the previous 5 years) or current therapy with anti IgE (e.g., omalizumab \[Xolair\]) or anti-interleukins (e.g., mepolizumab).
35. Current or past therapy (within the previous 5 years) with any other immunomodulatory biologics.
36. Unable to refrain from any vaccination (including influenza vaccine and COVID-19 vaccine) during the clinical trial (unless administered \>30 days prior to randomisation).
Please note: Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time. Booster vaccinations (only) for COVID-19 can be administered during the clinical trial apart from during the treatment period. There should be at least 14 days interval from the last administration of the investigational drug/placebo prior to administration of a COVID-19 booster injection.
37. Participation in a clinical research trial with any investigational drug within 4 weeks of Visit 1 or concomitantly with this clinical trial.
Please note: The period of exclusion begins at the time of the last visit of the prior clinical research trial. Subjects consented and screened, but not dosed in the prior clinical research trial are not excluded.
38. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
39. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
40. Subjects likely to have prolonged periods of absence (e.g., business or personal travel) during the GPS defined as:
* Absence of a total of 22 days or more in similar geographical regions (as determined by the Investigator), with no single trip in a similar geographical region exceeding 14 days.
* Absence of a total of 15 days or more in non-similar geographic regions (as determined by the Investigator), with no single trip in a non-similar geographical region exceeding 7 days.
41. Have changed residence to a different geographical region(s) since the last GPS.
Exception: The old and new residences are in the same or similar geographical region as determined by the Investigator.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Allergy Therapeutics
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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IMMUNOe Research Centers
Centennial, Colorado, United States
Site Status
Velocity Clinical Research Denver
Denver, Colorado, United States
Site Status
Allergy Partners of Central Kentucky
Lexington, Kentucky, United States
Site Status
Allergy and Asthma Associates of Bluegrass
Lexington, Kentucky, United States
Site Status
Family Allergy Asthma Research Institute
Louisville, Kentucky, United States
Site Status
Allergy & Asthma Specialists PSC
Owensboro, Kentucky, United States
Site Status
Northern Light Allergy and Immunology
Bangor, Maine, United States
Site Status
Paul A. Shapero M.D.
Bangor, Maine, United States
Site Status
Chesapeake Clinical Research Inc
White Marsh, Maryland, United States
Site Status
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
Site Status
Clinical Research of The Ozarks Inc - Warrensburg
Columbia, Missouri, United States
Site Status
Montana Medical Research
Missoula, Montana, United States
Site Status
Nebraska Medical Research Institute, The Asthma & Allergy Center
Bellevue, Nebraska, United States
Site Status
Parikh Institute for Research LLC
Highland Park, New Jersey, United States
Site Status
Atlantic Research Center LLC
Ocean City, New Jersey, United States
Site Status
Weiss Medical
Riverdale, New Jersey, United States
Site Status
Allergy Asthma and Immunology Research Institute
Charlotte, North Carolina, United States
Site Status
Cincinnati Allergy and Asthma Center
Cincinnati, Ohio, United States
Site Status
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Site Status
Optimed Research Ltd
Columbus, Ohio, United States
Site Status
Toledo Institute of Clinical Research Inc
Toledo, Ohio, United States
Site Status
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC - CRN - PPDS
Oklahoma City, Oklahoma, United States
Site Status
Velocity Clinical Research, Inc
Grants Pass, Oregon, United States
Site Status
Velocity Clinical Research - Medford - ERN - PPDS
Medford, Oregon, United States
Site Status
Northwest Research Center
Portland, Oregon, United States
Site Status
Allergy & Asthma Specialists
Blue Bell, Pennsylvania, United States
Site Status
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Site Status
Allergy Associate of Utah
Murray, Utah, United States
Site Status
Lysosomal Rare Disorders Research & Treatment Center
Fairfax, Virginia, United States
Site Status
Eastern Virginia Medical School
Norfolk, Virginia, United States
Site Status
Bellingham Asthma Allergy and Immunology Clinic
Bellingham, Washington, United States
Site Status
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Site Status
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Site Status
Medizinische Universitaet Innsbruck - Universitatsklinik fuer Dermatologie, Venerologie und Allergologie
Innsbruck, , Austria
Site Status
Bezirkskrankenhaus Kufstein
Kufstein, , Austria
Site Status
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, , Austria
Site Status
Ambulatorium für Allergie und klinische Immunologie AAKI
Vienna, , Austria
Site Status
Fakultní nemocnice u sv. Anny v Brně
Brno, , Czechia
Site Status
MUDr. Jana Poloniová - alergologie a klinická imunologie
České Budějovice, , Czechia
Site Status
Alergopraktik, s.r.o.
Jablonec nad Nisou, , Czechia
Site Status
Alergologie a imunologie MUDr. Hofstetr
Jihlava, , Czechia
Site Status
Alergoimuno s.r.o.
Ostrava-Hrabuvka, , Czechia
Site Status
ACREDULA BENEDICTA s.r.o.
Pardubice, , Czechia
Site Status
Fakultní nemocnice Plzeň
Pilsen, , Czechia
Site Status
KASMED, s.r.o.
Tábor, , Czechia
Site Status
MŮJ ALERGOLOG s.r.o.
Trutnov, , Czechia
Site Status
CIMS Studienzentrum Bamberg, GmbH
Bamberg, , Germany
Site Status
Charité - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie und Allergologie/ Abteilung Allergologie und Immunologie
Berlin, , Germany
Site Status
Praxis Dr. Petra El-Naib
Chemnitz, , Germany
Site Status
HNO-Praxis Dr. Udo Schaefer
Dresden, , Germany
Site Status
Klinische Forschung Dresden GmbH
Dresden, , Germany
Site Status
Praxis fuer HNO und Allergologie
Dresden, , Germany
Site Status
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Site Status
HNO-Praxis Dr. Uta Thieme
Duisburg, , Germany
Site Status
RKM740 Hals-Nasen-Ohrenheilkunde
Düsseldorf, , Germany
Site Status
Gemeinschaftspraxis Ruhr
Essen, , Germany
Site Status
Medizentrum Essen Borbeck
Essen, , Germany
Site Status
Medaimun GmbH
Frankfurt am Main, , Germany
Site Status
medicoKIT GmbH
Goch, , Germany
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Klinische Forschung Hamburg GmbH
Hamburg, , Germany
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Hamburger Institut für Therapieforschung GmbH
Hamburg, , Germany
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Velocity Clinical Research Hamburg
Hamburg, , Germany
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Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
Heidelberg, , Germany
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HNO-Praxis Landsberg
Landsberg, , Germany
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Praxis fuer Pneumologie und Allergologie
Leipzig, , Germany
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Sektion Rhinologie/Allergologie Klinik fuer HNO-Heilkunde, UKGM - Marburg
Marburg, , Germany
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Beldio Research GmbH
Memmingen, , Germany
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Facharztpraxis Dr. med. Jan-Christof Bohn
Mittweida, , Germany
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Ballenberger, Freytag, Wenisch Institut fuer klinische Forschung GmbH
Neu-Isenburg, , Germany
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Studienzentrum Maerkisch-Oderland
Neuenhagen, , Germany
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KliFOs - Klinische Forschung Osnabrueck
Osnabrück, , Germany
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Studienzentrum Dr. Sabine Lassmann
Saalfeld, , Germany
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Klinische Forschung Schwerin GmbH
Schwerin, , Germany
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Klinikum Stuttgart - Krankenhaus Bad Cannstatt (KBC) - Frauenklinik
Stuttgart, , Germany
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Dres. med. Josef und Wilma Grosskopf
Wallerfing, , Germany
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Gróf Tisza István Kórház Rendelőintézet MEDIDOCUMENT Kereskedelmi és Szolgáltató Betéti Társaság
Berettyóújfalu, , Hungary
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Clinexpert Kft
Budapest, , Hungary
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HiTech Medical Kft.
Budapest, , Hungary
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Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs, , Hungary
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Prywatny Gabinet Internistyczno - Alergologiczny
Bialystok, , Poland
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Allergy Clinic Homeo Medicus
Bialystok, , Poland
Site Status
Centrum Medyczne Czestochowa - PRATIA - PPDS
Częstochowa, , Poland
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Centrum Medyczne Pratia Katowice
Katowice, , Poland
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Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska
Katowice, , Poland
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ETG Kielce
Kielce, , Poland
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Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, , Poland
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Krakowskie Centrum Medyczne
Krakow, , Poland
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Malopolskie Centrum Alergologii
Krakow, , Poland
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Uniwersytecki Szpital Kliniczny im. Barlickiego, Poradnia alergologii i chorob pluc
Lodz, , Poland
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ETG Łódz
Lodz, , Poland
Site Status
Clinical Best Solutions Sp. Z O.O. Spółka Komandytowa
Lublin, , Poland
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Centrum Alergologii Teresa Hofman Sp. z o.o.
Poznan, , Poland
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Specjalistyczna Przychodnia Lekarska ALERGO-MED Sp. z.o.o.
Poznan, , Poland
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EMED Centrum Uslug Medycznych Ewa Śmiałek
Rzeszów, , Poland
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ETG Skierniewice
Skierniewice, , Poland
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ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, , Poland
Site Status
Specjalistyczne Centrum Medyczne Centermed Sp. z o.o.
Tarnów, , Poland
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IRMED Irena Wojciechowska
Warsaw, , Poland
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WK Medical Service Sp. z o.o.
Warsaw, , Poland
Site Status
"ALL-MED" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy
Wroclaw, , Poland
Site Status
Michał Bogacki - DOBROSTAN
Wroclaw, , Poland
Site Status
Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Lekarska Hipokrates Sp. z o.o.
Zabrze, , Poland
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Countries
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United States
Austria
Czechia
Germany
Hungary
Poland
References
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Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Wu LYD, Keane ST, Fulton WT, Hikmawati P, Meng X, Filipaviciute P, Cutrina Pons A, Oluwayi K, Lis K, Armfield O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Shamji MH. Modulation of Cellular, Molecular, and Humoral Responses by PQ Grass 27,600 SU for the Treatment of Seasonal Allergic Rhinitis: A Randomised Double Blind Placebo Control Exploratory Field Study. Allergy. 2025 Jul 8. doi: 10.1111/all.16640. Online ahead of print.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001517-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PQGrass306
Identifier Type: -
Identifier Source: org_study_id
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