- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05234580
Safety and Efficacy Study of PA9159 Nasal Spray for the Treatment of Seasonal Allergic Rhinitis
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Nasal Spray for the Treatment of Seasonal Allergic Rhinitis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yingchun Hu, phD
- Phone Number: +8618916880358
- Email: huyingchun@paloaltopharma.com
Study Contact Backup
- Name: Chunping Lu, Master
- Phone Number: +8615921612878
- Email: luchunping@paloaltopharma.com
Study Locations
-
-
Anhui
-
Bengbu, Anhui, China
- Not yet recruiting
- The First Affiliated Hospital of Bengbu Medical college
-
Contact:
- Huan Zhou
- Phone Number: 86-13665527160
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Principal Investigator:
- Shiyin Ma
-
Hefei, Anhui, China
- Not yet recruiting
- The Second Hospital of Anhui Medical University
-
Contact:
- Wei Hu
- Phone Number: 86-13856086475
-
Principal Investigator:
- Jianming Yang
-
-
Beijing
-
Beijing, Beijing, China
- Not yet recruiting
- Beijing Shijitan Hospital
-
Contact:
- Xinna Zhou
- Phone Number: 86-13810967206
-
Principal Investigator:
- Haiyun Shi
-
Beijing, Beijing, China
- Recruiting
- Beijing Tongren Hospital
-
Contact:
- Yuyang Dai
- Phone Number: 86-10-5826848
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Principal Investigator:
- Luo Zhang, MD
-
Beijing, Beijing, China
- Not yet recruiting
- Dongfang Hospital Beijing University of Chinese Medicine
-
Contact:
- Wenna Liu
- Phone Number: 86-1067689923
-
Principal Investigator:
- Lei Ding
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Renmin Hospital of Wuhan University
-
Contact:
- Jian Zhou
- Phone Number: 86-27-88237069
-
Principal Investigator:
- Yu Xu
-
-
Jiangsu
-
Yangzhou, Jiangsu, China
- Recruiting
- Northern Jiangsu People's Hospital
-
Contact:
- Guo Yu
- Phone Number: 86-514-87373415
-
Principal Investigator:
- Bing Guan
-
-
Jilin
-
Changchun, Jilin, China
- Not yet recruiting
- The Affiliated Hospital of Changchun University of Chinese medicine
-
Contact:
- Haimiao Yang
- Phone Number: 86-15948000728
-
Principal Investigator:
- Mei Han
-
Tonghua, Jilin, China
- Not yet recruiting
- Tonghua Central Hospital
-
Contact:
- Na Liu
- Phone Number: 86-13944589985
-
Principal Investigator:
- Yaowu Dong
-
Yanji, Jilin, China
- Not yet recruiting
- Yanbian Korea Medicine Hospital
-
Contact:
- Wenjun Jin
- Phone Number: 86-13704385316
-
Yanji, Jilin, China
- Not yet recruiting
- YANBIAN University Hospital(Yanbian Hospital)
-
Contact:
- Hongxin Piao
- Phone Number: 86-15526770394
-
Principal Investigator:
- Yongde Jin
-
-
Shandong
-
Qingdao, Shandong, China
- Not yet recruiting
- The Affiliated Hospital of Qingdao University
-
Contact:
- Yu Cao
- Phone Number: 86-532-82911767
-
Principal Investigator:
- Yan Jiang
-
Yantai, Shandong, China
- Not yet recruiting
- Yantai Yuhuangding Hospital
-
Principal Investigator:
- Xicheng Song
-
Contact:
- Weiwei Zhu
- Phone Number: 86-15698187866
-
Zibo, Shandong, China
- Recruiting
- Zibo central Hospital
-
Contact:
- Xiaoming Pang
- Phone Number: 86-533-2361126
-
Principal Investigator:
- Yunpei Zhao
-
-
Shanxi
-
Taiyuan, Shanxi, China
- Recruiting
- First Hospital Of ShanXi Medical University
-
Contact:
- Zhongguo Liu
- Phone Number: 86-351-4639071
-
Principal Investigator:
- Qinna Zhang
-
Taiyuan, Shanxi, China
- Not yet recruiting
- Second Hospital of Shanxi Medical University
-
Contact:
- Yi Zhao
- Phone Number: 86-15235171598
-
Principal Investigator:
- Jinmei Xue
-
-
Tianjin
-
Tianjin, Tianjin, China
- Not yet recruiting
- General Hospital of Tianjin Medical University
-
Contact:
- Qingyu Zhang
- Phone Number: 86-22-60361044
-
Principal Investigator:
- Huifang Zhou
-
Tianjin, Tianjin, China
- Not yet recruiting
- Tianjin People's Hospital
-
Contact:
- Wei Cui
- Phone Number: 86-22-27557550
-
Principal Investigator:
- Jixiang Liu
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Zhejiang Provincial People's Hospital
-
Contact:
- Sisi Lin
- Phone Number: 86-18806532023
-
Principal Investigator:
- Lizhong Su
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 12 years, male or female;
Clinical diagnosis is based on the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2018 Edition) issued by the Rhinology Group of the Otorhinolaryngology Head and Neck Surgery Branch of the Chinese Medical Association, with a clear history of Seasonal Allergic Rhinitis (SAR) ≥ 1 year (written or verbal confirmation), and positive test for one or more allergens before randomization. Recognize the results of any one of the skin prick test (SPT), intradermal test, and serum specific IgE test; Clinical manifestations may include:
- Symptoms: 2 or more symptoms such as sneezing, runny nose, itchy nose and nasal congestion, lasting or accumulating for more than 1 h each day, may be accompanied by ocular symptoms such as itching, lacrimation, and red eyes;
- Signs: pallor and edema of the nasal mucosa and watery nasal secretions;
- Allergic symptoms are characterized by seasonal onset in spring and/or fall, and at the time of this enrollment, it is during the onset of symptoms.
- Reflective Total Nasal Symptom Score (rTNSS) ≥ 6 points, nasal congestion ≥ 2 points, and one of the three symptoms of sneezing, runny nose and itchy nose ≥ 2 points, all these three conditions are met simultaneously at the time of screening, baseline and the first dosing during treatment; The mean rTNSS at baseline was the mean of a total of 8 scores on evening of D-4, morning and evening of D-3, D-2 and D-1, and the morning of D1;
- Capable of demonstrating the correct use of nasal spray techniques after training at screening;
- Capable of performing respiratory exercise as required at the time of intranasal administration after training at screening;
- Is willing to sign the informed consent form (ICF), comply with the study procedures, including the correct use of the nasal spray device, and understand and accurately record the patient diary card; Ability to understand and receive treatment, laboratory tests, and other study procedures as planned.
Exclusion Criteria:
- Previous intolerance to intranasal administration;
- Patients with asthma requiring long-term treatment (patients with occasional acute asthma, or mild, exercise-induced asthma requiring no medication or only beta-agonist treatment during the study may be included);
- Active or inactive tuberculosis infection, untreated local or systemic fungal, bacterial, viral, or parasitic infection;
- Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections (except allergic conjunctivitis);
- Any nasal mucosal erosion, septal ulceration, or nasal septal perforation at screening or prior to the first dose on D1;Presence of other nasal disorders that may affect intranasal drug deposition as judged by the investigator, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, or nasal septal deviation;
- History with sinus surgery within 3 months or nasal trauma that have not completely healed;
- Respiratory tract infections treated with antibiotics within 4 weeks prior to screening;
- Patients with severe lung diseases, such as COPD (chronic obstructive pulmonary disease), etc.;
- Patients with unstable heart disease with drug-control;
- Patients who have received desensitization therapy within 6 months prior to screening;
- Severe liver and kidney disease, or abnormal liver and kidney function tests (ALT, AST ≥ 2 times the upper limit of normal, or Cr > 1.2 times the upper limit of normal);
- Use of short-lasting prescriptions and OTC antihistamines within 3 days prior to screening; Use of nasal glucocorticoids within four weeks; Inhalation, oral, intramuscular/intravascular injection, topical hormones (except hydrocortisone cream containing ≤ 1%) within 8 weeks prior to screening; Use of nasal or ophthalmic cromoglycic acid within 14 days prior to screening; Use of long-lasting antihistamines such as loratadine, desloratadine, fexofenadine, or cetirizine within 10 days prior to screening; Oral or nasal decongestants, nasal anticholinergics, or oral antileukotrienes within 72 h prior to screening; Use of Omalizumab subcutaneously within 5 months prior to screening; Use of anti-allergic Chinese herbal medicines within 14 days prior to screening.
- Planned use of the following medications or/and treatments during the study: a. Strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, etc.; b. Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent topical corticosteroids; c. Antihistamines (except salvage medications required during the trial); d. Leukotriene modulators; e. Mast cell membrane stabilizers (including cromoglycate sodium, nidolate sodium, tetrazolone, nedocromil sodium, pemirolast potassium, and tranilast, etc.); f. Decongestants; g. Anticholinergics; h. Immunotherapeutic agents; i. Anti-allergic Chinese herbal medicine;
- Planned to travel outside the local area for 2 consecutive days (48 h) or a total of more than 3 days during the trial;
- Alcohol addicts in the previous 1 year (alcoholism defined as: greater than 14 units of alcohol per week;1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits or 150 mL of wine containing 40% alcohol), drug abusers, drug addicts, or smoking addicts (average of more than 10 cigarettes per day);
- Allergic to the investigational drug and its excipients;
- Pregnant or lactating women, and male subjects (or their partners) or female subjects who have a pregnancy plan throughout the trial and for 3 months after the end of the study;
- Participated in other drug clinical trials within 3 months prior to screening, and used the study drug;
- Based on the judgment of the investigator, the subject may have an impact on compliance with any aspect of the protocol (including visit plan and completion of diary cards or questionnaires) due to physical, educational level, or geographic location;
- Based on the opinion of the investigator, there are any circumstances that may affect the subject's informed consent or compliance with the protocol, or that the subject's participation in the trial may affect the results of the study or their own safety.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PA9159 10 μg
Fifty subjects will be randomly assigned to receive 10 μg of PA9159 Nasal Spray for 14 days.
Subjects will be administered two vials of drug (spray bottle A and spray bottle B) once daily in the morning, one spray each in the left and right nostril, in the order of first spray A and then spray B. Spray Bottle A: 5 μg/spray; Spray Bottle B: 0 μg/spray.
|
PA9159 of 10 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
|
Experimental: PA9159 20 μg
Fifty subjects will be randomly assigned to receive 20 μg of PA9159 Nasal Spray for 14 days.
Subjects will be administered two vials of drug (spray bottle A and spray bottle B) once daily in the morning, one spray each in the left and right nostril, in the order of first spray A and then spray B. Spray Bottle A: 0 μg/spray; Spray Bottle B: 10 μg/spray.
|
PA9159 of 20 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
|
Experimental: PA9159 40 μg
Fifty subjects will be randomly assigned to receive 40 μg of PA9159 Nasal Spray for 14 days.
Subjects will be administered two vials of drug (spray bottle A and spray bottle B) once daily in the morning, one spray each in the left and right nostril, in the order of first spray A and then spray B. Spray Bottle A: 10 μg/spray; Spray Bottle B: 10 μg/spray.
|
PA9159 of 40 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
|
Placebo Comparator: Placebo
Fifty subjects will be randomly assigned to receive placebo Nasal Spray without active of PA9159 for 14 days.
Subjects will be administered two vials of drug (spray bottle A and spray bottle B) once daily in the morning, one spray each in the left and right nostril, in the order of first spray A and then spray B. Spray Bottle A: 0 μg/spray; Spray Bottle B: 0 μg/spray.
|
Placebo nasal spray solution is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation the change from baseline in daily subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation the proportion and frequency of patients using the antihistamine drug of loratadine tablets during the treatment period;
Time Frame: From pre-dose until 14 days post-dose
|
If the subject is intolerant of symptoms, loratadine tablets may be taken with the consent of the investigator, 10 mg once a day, without overdose; If symptoms improve, they will no longer be used; It can be used once or continuously for ≤ 3 days, preferably avoiding intermittent use.
Continue study drug while taking salvage medication.
|
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in daily subject-reported AM and PM Instantaneous Total Nasal Symptoms Scores (iTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Instantaneous Total Nasal Symptoms Scores (iTNSS) measures these symptoms over the previous 10 minute time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the Area Under the Curve (AUC) of Reflective Total Nasal Symptom Score (rTNSS) over time in subjects.
Time Frame: From pre-dose until 14 days post-dose
|
The parameter of AUC was produced based on the Reflective Total Nasal Symptom Score (rTNSS) obtained daily over the 14-day treatment period.
|
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in subject-reported Instantaneous Total Nasal Symptoms Scores (iTNSS) at 4 h ± 0.5 h, 8 h ± 0.5 h, and 12 h ± 1 h after the first dose in the treatment period.
Time Frame: Day 1 of the first dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Instantaneous Total Nasal Symptoms Scores (iTNSS) measures these symptoms over the previous 10 minute time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
Day 1 of the first dose
|
Evaluation the change from baseline in daily subject-reported AM Reflective Total Nasal Symptom Score (rTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in daily subject-reported PM Reflective Total Nasal Symptom Score (rTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the percentage change from baseline in subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) averaged on a subject-day basis.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the percentage change from baseline in daily subject-reported AM Instantaneous Total Nasal Symptoms Scores (iTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Instantaneous Total Nasal Symptoms Scores (iTNSS) measures these symptoms over the previous 10 minute time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the percentage change from baseline in daily subject-reported PM Instantaneous Total Nasal Symptoms Scores (iTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Instantaneous Total Nasal Symptoms Scores (iTNSS) measures these symptoms over the previous 10 minute time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the percentage change from baseline in daily subject-reported AM Reflective Total Nasal Symptom Score (rTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the percentage change from baseline in daily subject-reported PM Reflective Total Nasal Symptom Score (rTNSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Nasal Symptom Score (TNSS) is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Nasal Symptom Score (rTNSS) measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in overall score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in participants over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). Therefore, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) values range from 0-168 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in overall score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) in participants over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
The Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) has 16 items in 4 domains (problems with sleep, symptoms during sleep time, symptoms on waking in the morning and practical problems). Each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Patients recall their experiences during the previous week and respond to each question. Therefore, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) values range from 0-96 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms).Difference was calculated as the 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in daily subject-reported AM and PM Reflective Total Ocular Symptom Score (rTOSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Ocular Symptom Score (TOSS) is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Reflective Total Ocular Symptom Score (rTOSS) symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline in daily subject-reported AM and PM Instantaneous Total Ocular Symptoms Scores (iTOSS) averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
Total Ocular Symptom Score (TOSS) is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
The parameter of Instantaneous Total Ocular Symptoms Scores (iTOSS) symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as 14-day treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
From pre-dose until 14 days post-dose
|
Evaluation the change from baseline of each individual rhinitis symptom score averaged over the 14-day treatment period.
Time Frame: From pre-dose until 14 days post-dose
|
The individual rhinitis symptoms are runny nose, sneezing, itchy nose, and nasal congestions.
Difference was calculated as the 14-day treatment average - baseline.
Greater reductions in the change from baseline score indicate greater improvement.
|
From pre-dose until 14 days post-dose
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luo Zhang, phD, Beijing Tongren Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA9159-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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