Allergic rhinitis
Conditions
Interventions
Experimental group :PG-011 nasal spray
Control group:Placebo
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old =65 years old, male or female; 2. Participants meet the following criteria at screening,D-4, and D1: 1) rTNSS score =6; 2) Nasal congestion =2 points; 3. Participants has moderate-to- severe seasonal allergic rhinitis, and has clear medical history = 1 year and have positive tests for skin prick test (SPT) or serum specific IgE (sIgE); 4. Female participants of reproductive age and all male participants must commit to using at least one effective contraceptive method from signing the informed consent until one month after the final administration of the investigational drug; 5. Willing to sign the informed consent and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Active or latent respiratory tuberculosis infection, or a history of tuberculosis; 2.Moderate to severe asthma; 3.Eye herpes simplex or other eye infections (excluding allergic conjunctivitis); 4.Any nasal mucosal erosion, nasal septum ulcer or perforation, or other nasal conditions that may affect intranasal drug deposition, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, or nasal septum abnormalities; 5.Unresolved or ongoing treatment-requiring facial or systemic fungal, bacterial, viral, or parasitic infections, or oral infections within 4 weeks before screening; 6.Respiratory tract infections requiring antibiotic treatment within 4 weeks before screening; 7.Underwent sinus surgery or had unresolved nasal trauma within 3 months before screening; 8.Severe central nervous system, respiratory, liver, kidney, gastrointestinal, urinary, endocrine, or hematologic diseases that may affect the efficacy and safety assessments of the subject, as judged by the investigator; 9.Human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA >2,000 IU/mL or 104 copies/mL), or positive for treponema pallidum antibody indicating an active infection at the time of screening; 10.Subjects who have received the following medications before the run-in period (including but not limited to the following drugs): Nasal or systemic decongestants and anticholinergic drugs within 3 days; Antihistamines such as cetirizine, fexofenadine and loratadine within 5 days; Systemic or topical corticosteroids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists within 4 weeks; Anti-allergic Chinese herbal medicines within 2 weeks; 11.Subjects unable to discontinue the use of JAK inhibitors, tricyclic antidepressants, corticosteroids, decongestants, antihistamines (except loratadine used as rescue medication during the treatment period), leukotriene receptor antagonists, mast cell membrane stabilizers (including sodium cromoglicate, nedocromil sodium, 6-ethyl-3-(1H-tetrazol-5-yl)chromone, pemirolast potassium, and tranilast), anticholinergic drugs, anti-allergic Chinese herbal medicines, and nasal irrigation during the study period; 12.Subjects who have undergone desensitization therapy or received immunotherapy within 6 months before screening; 13.Subjects with a known allergy or, in the investigator’s judgment, a potential allergic reaction to the active ingredients or excipients of the study drug; 14.Subjects found to respond to placebo during the run-in period: moderate or more severe rhinitis symptoms during the screening period that improve to mild or no symptoms during the run-in period, or a baseline mean rTNSS <6; 15.Subjects previously unable to tolerate intranasal administration; 16.Subjects planning to travel outside the local area for 2 or more consecutive days during the study period; 17.Subjects who have participated in other investigational drug or medical device clinical trials within 3 months before screening; 18.Subjects with a history of drug abuse or alcoholism within 1 year before screening; 19.Female subjects who are breastfeeding or pregnant at the time of screening; 20.Subjects of childbearing potential (male or female) planning to become pregnant, breastfeed, or donate sperm/eggs during the study or within 1 month after the end of the study; 21.A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the mean rTNSS over 14 days of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the mean iTNSS over 14 days of treatment;Change from baseline in the mean rTOSS over 14 days of treatment ;Change from baseline in the mean iTOSS over 14 days of treatment;Changes from baseline in the morning and evening mean rTNSS over 14 days of treatment;Changes from baseline in the morning and evening mean iTNSS over 14 days of treatment;Changes from baseline in the morning and evening mean rTOSS over 14 days of treatment;Changes from baseline in the morning and evening mean iTOSS over 14 days of treatment;Changes from baseline in individual reflective nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 14 days of treatment;Changes from baseline in individual reflective nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) in the morning and evening over 14 days of treatment;Changes from baseline in individual reflective ocular symptoms (ocular itching/grittiness/redness, ocular tearing) over 14 days of treatment;Changes from baseline in individual reflective ocular symptoms (ocular itching/grittiness/redness, ocular tearing) in the morning and evening over 14 days of treatment;Use of rescue medication during the treatment period (proportion of patients and frequency);Changes from baseline in the RQLQ score during the treatment period; | — |
Countries
China
Contacts
Public ContactZhang Luo
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed