Allergic rhinitis
Conditions
Interventions
PG-011 nasal spray 0.3%:2 sprays in each nostril, twice daily for 14-day treatment period.
PG-011 nasal spray 0.6%:2 sprays in each nostril, once daily for 14-day treatment period.
PG-011 nasal spray 0.6%:2 sprays in each nostril, twice daily for 14-day treatment period.
Vehicle nasal spray:2 sprays in each nostril, twice daily for 14-day treatment period.
PG-011 nasal spray 0.6%:2 sprays in each nostril, twice daily for 14-day treatment period.
Vehicle nasal spray:2 sprays in each nostril, twice daily for 14-day treatment period.
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: IIb Part: 1. Male or female aged 18 to 65 (including threshold). 2. Reflective total nasal symptom score ( rTNSS) score >= 6 and retrospective nasal obstruction >= 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) >= 6 3. History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within = 1 year before random enrollment are acceptable). 4. Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until one month after the last administration of the investigational medicinal product. 5. Willing to sign the informed consent form and abide by the research protocol. Phase III 1. Male or female aged 18 to 65 (including threshold). 2. Reflective total nasal symptom score ( rTNSS) score= 6 and retrospective nasal obstruction = 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) = 6 3. History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within = 1 year before random enrollment are acceptable). 4. Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until three month after after the end of the study. 5. Willing to sign the informed consent form and abide by the research protocol.
Exclusion criteria
Exclusion criteria: IIb Part 1. Participants are diagnosed of active or latent tuberculosis infection. 2. Participants are diagnosed of moderate to severe asthma. 3. Participants who had active pulmonary diseases or infections (including but not limited to bronchitis, pneumonia), upper respiratory tract infections or sinus infections within 4 weeks before screening, and/or those who had respiratory infections during the lead-in period. 4.Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed. 5. Any nasal mucosal erosion, nasal septal ulcer, nasal septal perforation or other nasal diseases that, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc. 6. Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis). 7. Participants with facial or systemic fungal, bacterial, viral or parasitic infections, or oral infections that had not been cured and still required continuous treatment within 4 weeks before screening. 8. Participants have severe diseases such as central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, which may affect the judgment of efficacy and safety . 9. Participants who were infected with human immunodeficiency virus (HIV) at the time of screening, those in the active stage of hepatitis C virus (HCV) infection (anti - HCV positive), those in the active stage of hepatitis B virus (HBV) infection (HBV - DNA > 2000 IU/mL or 104 copies/mL), or those with positive Treponema pallidum antibody indicating an active stage of infection. 10. Any drug treatments before lead-in period, such as use of nasal or systemic decongestants and anticholinergic drugs within 3 days, use of antihistamines such as cetirizine, fexofenadine, and loratadine within 5 days, systemic use of glucocorticoids within 4 weeks, or local use of glucocorticoids, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks. 11. During the trial, participants who cannot stop using JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except loratadine, which is a rescue drug required during the treatment), leukotriene receptor antagonists, mast cell stabilizers (including sodium cromoglycate, nedocromil sodium, tetrazolium chromone, nedocromil sodium, pemirolast potassium, and tranilast, etc.), anticholinergic drugs, anti - allergic Chinese herbal medicines, and those who cannot stop using nasal irrigation. 12. Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening. 13. Participants who are known or judged by the investigator to potentially have an allergic reaction to the active ingredients or excipients of the investigational drug. 14. Participants who have a history of intolerance to intranasal administration. 15. Participants who plan to travel outside the local area for 2 consecutive days or more during the trial. 16. Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening. 17. Participants who have a history of drug abuse or alcoholism within 1 year prior to screening 18. Female participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period; Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period;Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period;Change and percent change from baseline in average instantaneous ocular symptom score (iTOSS) over 14-day treatment period; Change from baseline in AM participant-reported rTNSS over the 14-day treatment period ; Change from baseline in PM participant-reported rTNSS over the 14-day treatment period; Change from baseline in AM participant-reported iTNSS over the 14-day treatment period ; Change from baseline in PM participant-reported iTNSS over the 14-day treatment period ; Change from baseline in AM participant-reported rTOSS over the 14-day treatment period.; Change from baseline in PM participant-reported rTOSS over the 14-day treatment period.; Change from baseline in AM participant-reported iTOSS over the 14-day treatment period.; Change from baseline in PM participant-reported iTOSS over the 14-day treatment period.; The mean change from baseline in the daily rTNSS ; The mean change from baseline in the daily iTNSS ; The mean change from baseline in the daily rTOSS; The mean change from baseline in the daily iTOSS; The mean change from baseline in the daily AM rTNSS ; The mean change from baseline in the daily PM rTNSS; The mean change from baseline in the daily AM iTNSS ; The mean change from baseline in the daily PM iTNSS; The mean change from baseline in the daily AM rTOSS ; The mean change from baseline in the daily PM rTOSS; The mean change from baseline in the daily AM iTOSS ; The mean change from baseline in the daily PM iTOSS; The mean change from baseline in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of rTNSS over | — |
Countries
China
Contacts
Public ContactZhang Luo
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed