Created at Source Raw Value Validated value
June 25, 2024, noon usa

* participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (copd), and currently suffering from chronic rhinitis or acute/chronic sinusitis. * participants who report any of the following at screening: 1. ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing. 2. participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes). 3. non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others. 4. participants who are current smokers. 5. known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product. 6. use of systemic immunomodulatory medications (thalidomide, lenalidomide, pomalidomide, imiquimod, etc.), anticoagulants, and other drugs assessed by the site investigator within the 4 weeks prior to study enrollment. 7. history of alcohol/ substance abuse within 6 months of study enrollment. 8. history of any vaccinations within the 2 weeks prior to enrollment. 9. participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment. 10. having plans to relocate away from the study site area during the period of study participation. * has any of the following laboratory abnormalities at screening: 1. white blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3. 2. hemoglobin \<12 g/dl for men and \<11 g/dl for women. 3. calculated creatinine clearance \>1.1 x upper limit of normal (uln). 4. alanine transaminase (alt) and/or aspartate aminotransferase (ast) \> 1.1 × the site laboratory uln. 5. total bilirubin \> 1.1 x uln. 6. ≥ +1 glucose or +2 protein on urinalysis (ua). * any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.

* participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (copd), and currently suffering from chronic rhinitis or acute/chronic sinusitis. * participants who report any of the following at screening: 1. ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing. 2. participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes). 3. non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others. 4. participants who are current smokers. 5. known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product. 6. use of systemic immunomodulatory medications (thalidomide, lenalidomide, pomalidomide, imiquimod, etc.), anticoagulants, and other drugs assessed by the site investigator within the 4 weeks prior to study enrollment. 7. history of alcohol/ substance abuse within 6 months of study enrollment. 8. history of any vaccinations within the 2 weeks prior to enrollment. 9. participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment. 10. having plans to relocate away from the study site area during the period of study participation. * has any of the following laboratory abnormalities at screening: 1. white blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3. 2. hemoglobin \<12 g/dl for men and \<11 g/dl for women. 3. calculated creatinine clearance \>1.1 x upper limit of normal (uln). 4. alanine transaminase (alt) and/or aspartate aminotransferase (ast) \> 1.1 × the site laboratory uln. 5. total bilirubin \> 1.1 x uln. 6. ≥ +1 glucose or +2 protein on urinalysis (ua). * any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.

June 30, 2022, 10:30 p.m. usa

participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (copd), and currently suffering from chronic rhinitis or acute/chronic sinusitis. participants who report any of the following at screening: ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing. participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes). non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others. participants who are current smokers. known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product. use of systemic immunomodulatory medications (thalidomide, lenalidomide, pomalidomide, imiquimod, etc.), anticoagulants, and other drugs assessed by the site investigator within the 4 weeks prior to study enrollment. history of alcohol/ substance abuse within 6 months of study enrollment. history of any vaccinations within the 2 weeks prior to enrollment. participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment. having plans to relocate away from the study site area during the period of study participation. has any of the following laboratory abnormalities at screening: white blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3. hemoglobin <12 g/dl for men and <11 g/dl for women. calculated creatinine clearance >1.1 x upper limit of normal (uln). alanine transaminase (alt) and/or aspartate aminotransferase (ast) > 1.1 × the site laboratory uln. total bilirubin > 1.1 x uln. ≥ +1 glucose or +2 protein on urinalysis (ua). any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.

participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (copd), and currently suffering from chronic rhinitis or acute/chronic sinusitis. participants who report any of the following at screening: ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing. participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes). non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others. participants who are current smokers. known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product. use of systemic immunomodulatory medications (thalidomide, lenalidomide, pomalidomide, imiquimod, etc.), anticoagulants, and other drugs assessed by the site investigator within the 4 weeks prior to study enrollment. history of alcohol/ substance abuse within 6 months of study enrollment. history of any vaccinations within the 2 weeks prior to enrollment. participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment. having plans to relocate away from the study site area during the period of study participation. has any of the following laboratory abnormalities at screening: white blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3. hemoglobin <12 g/dl for men and <11 g/dl for women. calculated creatinine clearance >1.1 x upper limit of normal (uln). alanine transaminase (alt) and/or aspartate aminotransferase (ast) > 1.1 × the site laboratory uln. total bilirubin > 1.1 x uln. ≥ +1 glucose or +2 protein on urinalysis (ua). any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.