Seasonal Allergic Rhinitis
Conditions
Interventions
GSP 301 NS:Intranasal drug delivery
Patanase NS:Intranasal drug delivery
Nasonex NS:Intranasal drug delivery
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant females aged >=12 years; 2. Signed informed consent/assent form (subject and/or parent/caregiver/legal guardian); 3. Clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1], proof of medical records/prescriptions/allergy testing reports etc. is required) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the spring and/or fall allergy seasons and exhibiting a documented positive skin prick test (wheal diameter at least 5 mm greater than negative diluent control wheal) or positive serum specific IgE (above 0.35KU/L) to spring and/or fall allergens. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable; 4. A 12-hour reflective Total Nasal Symptom Score (rTNSS) >=8 out of a possible 12 and a congestion score >=2 for the morning (AM) assessment at the Screening Visit (Visit 1); 5. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of study results as determined by the Investigator; 6. Subjects must be able to demonstrate the correct NS application technique at the Screening Visit (Visit 1); 7. Subjects must be willing and able to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: 1. Have a positive blood HCG test or established pregnancy, breastfeeding, or be planning a pregnancy during the study; 2. Female subjects of child-bearing potential (i.e. female subjects between the onset of menstruation and up to 1 year after menopause) who do not agree to remain abstinent or use medically acceptable methods of contraception (e.g., implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], double-barrier protection) during the study. Male participants who do not agree to use a condom during intercourse (if not surgically sterilized) during the study; 3. Plans to travel outside the known pollen area for the investigational site during the run-in period; 4. Plans to travel outside the known pollen area for the investigational site between the Randomization Visit (Visit 2) and the Final Visit (Visit 4); 5. History of significant atopic dermatitis or rhinitis medicamentosa (within 60 days prior to the Screening Visit [Visit 1]); 6. Treatment with any known potent CYP3A4 inducers (carbamazepine, dexamethasone, phenytoin, rifabutin, rifampin, pioglitazone, etc.) or potent inhibitors (e.g., azole antifungals, macrolide antibiotics) within 30 days prior to or during the study; 7. Exposure to or active infection with significant viral infections (e.g.,chickenpox or measles but not limited to) within the 21 days preceding the Screening Visit (Visit 1); 8. Known hypersensitivity to any corticosteroids or antihistamines or to the study drug or its excipients; 9. History of severe anaphylaxis and/or other severe local reaction(s) to skin testing; 10. History of alcohol or drug dependence within 2 years preceding the Screening Visit (Visit 1); 11. History of a positive test for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen, Hepatitis C antibody, or treponema pallidum antibody; 12. Evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip; 13. Any of the following conditions (including but not limited to the following) that are judged by the Investigator to be clinically significant and/or to affect the subjects ability to participate in this study: (1) Impaired hepatic function including alcohol-related liver disease or cirrhosis; (2) Any systemic infection; (3) Hematological, hepatic, renal, endocrine disorder (except for postmenopausal symptoms or hypothyroidism); (4) Gastrointestinal disease; (5) Malignancy (excluding basal cell carcinoma); (6) Current neuropsychological condition with or without drug therapy; (7) Cardiovascular disease (e.g., uncontrolled hypertension); (8) Respiratory disease other than mild asthma; 14. Any major surgery (as assessed by the Investigator) within 4 weeks of the Screening Visit (Visit 1); 15. Requirement for the chronic use of tricyclic anti-depressants; 16. Dependence (in the opinion of the Investigator) on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids. 17. Active pulmonary disorder or infection (including but not limited to bronchitis, pneumonia, or influenza), or upper respiratory tract or sinus infection within the 14 days prior to the Screening Visit (Visit 1) or the development of respiratory infections during the run-in period. Subjects with mild asthma are allowable on the condition that treatment is limited to inhaled short-acting beta-agonists only (up to 8 puffs per day); 18. Use of antibiotic therapy for any conditions within 14 days prior to t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflective Total Nasal Symptom Score (rTNSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Instantaneous Total Nasal Symptom Score (TNSS);Reflective Total Ocular Symptom Score (rTOSS);Rhinoconjunctivitis Quality-of-Life Questionnaire -Standardized Activities(RQLQ(S)); | — |
Countries
China
Contacts
Public ContactLuo Zhang
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed