Phase
Condition
Nasal Obstruction
Common Cold
Allergy
Treatment
LP-003 dose 1
Placebo
LP-003 dose 2
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18 to 65 years at the screening period
- Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelinesfor the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022) : a.Clinical symptoms: more than 2 (including 2 items) symptoms of sneezing, rhinorrhea,nasal congestion, nasal itching and other symptoms appear, which last or accumulatefor more than 1h per day and may be accompanied by ocular symptoms such as itchy eyes/tearing/ redness and burning heat sensation; b. Physical signs: pale, edema of thenasal mucosa and nasal watery discharge; c. Allergen detection: positive of at least 1allergen skin prick test(SPT) and/or serum-specific IgE within 1 year beforeenrollment, or nasal provocation test positive
- Had inadequately controlled symptoms (≥TNSS score of 6 and ≥ nasal congestion score of
- of seasonal allergic rhinitis in last two years despite the use of nasalcorticosteroid or in combination of one anti-histamine recommended by Guidelines.
- Having any nasal symptom last for at least 2 days or any nasal and eye symptom lastfor at least one day, and ≥TNSS score of 1
- Subjects (including partners) have no pregnancy and sperm, egg donation plan andvoluntarily take one or more non-pharmaceutical measures for contraception, such ascomplete abstinence, intrauterine ring, partner ligation at period from drugadministration to 6 months after the last study drug administration
- voluntary participation in this trial and signing the informed consent form
Exclusion
Exclusion Criteria:
- History of hypersensitivity to any content of the study drugs or its excipients..
- Subjects with non-allergic rhinitis combined, such as drug rhinitis, vasomotorrhinitis, Nonallergic rhinitis with eosinophilia syndrome, acute and chronicsinusitis, rhinitis sicca anterior, atrophic rhinitis, obvious deviation of nasalseptum
- Subjects with perennial allergic rhinitis ( except for seasonal allergic rhinitiscombined with perennial allergic rhinitis, which get attacks seasonally )
- Subjects who have undergone nasal surgery or sinus surgery within 1 year beforescreening
- Subjects who suffer from glaucoma, cataracts, herpes simplex keratitis, infectiousconjunctivitis or currently and other eye infections ( Except for allergicconjunctivitis )
- Subjects with active facial or systemic fungal, bacterial, viral or parasiticinfection, and oral candida infection, who still require ongoing treatment
- With clinically significant uncontrolled systemic disease (unstable ischemic heartdisease, NYHA class III/IV left ventricular failure, arrhythmias, uncontrolledhypertension, cerebrovascular disease, neurodegenerative disease, other neurologicaldisorders, uncontrolled hypothyroidism or hyperthyroidism and other autoimmunedisorders, hypokalemia, hyperadrenergic status, diagnosed as a malignancy in the past,except for basal cell carcinoma or squamous cell skin cancer ) ; History of myocardialinfarction (MI) within 1 year prior to the screening
- In screening period: a) WBC < 2.5×10^9/L, b)AST or ALT > 2.0×ULN or TBIL > 1.5×ULN, c)Cr > 1.5×ULN
- Subjects who have been treated by Omalizumab or other similar drugs within 6 monthsprior to the screening
- Subjects who have taken systemic glucocorticoids within 4 weeks prior to the screening
- Subjects who have taken intranasal glucocorticoids, mast cell membrane stabilizers,tricyclic antidepressants, leukotriene receptor antagonists, antihistamines within 1week prior to the screening
- Subjects who have taken traditional Chinese medicine for allergic rhinitis within 7days prior to the screening
- Subjects who have received allergen immunotherapy within half of year prior to thescreening (in treatment), or who have received allergen immunotherapy within 3 yearsprior to the screening ( completed treatment )
- During the study period, in addition to standard treatment concomitant drugs andsalvage therapy drugs specified in the protocol. Subjects are prohibited from takingmedications such as anticholinergics (oral and intranasal anticholinergics, includingipratropium nasal sprays), glucocorticoids, leukotriene receptor antagonists,antihistamines, mast cell membrane stabilizers, decongestants, nasal saline flushing,tricyclic antidepressants, antiallergic Chinese herbal medicines, immunosuppressants,immunomodulators and immunotherapy
- Subjects with serious organic diseases such as heart, lung, liver, kidney
- Subjects with poor compliance, such as poor medication compliance, inability to fillin diary cards correctly, and use of prohibited medications
- Who combined with nerve and mental illness that could not or unwilling to follow thestudy, and with disabilities as prescribed by law (blind, deaf, mute, mentallydisabled, mentally disabled, etc.)
- Who plan to travel to other regions in which there is no allergic pollen during thestudy period for more than two consecutive days or three accumulated days
- Pregnant or lactating women and women who plan pregnancy
- Participated in other clinical studies within 3 months prior to the start of the study
- Any condition that the investigator or primary physician believes may not beappropriate for participating the study
Study Design
Study Description
Connect with a study center
Beijing Shijitan Hospital
Beijing, Beijing 100038
ChinaActive - Recruiting
Dongfang Hospital
Beijing, Beijing
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, Beijing
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing
ChinaSite Not Available
Zhengzhou central hospital
Zhengzhou, Henan
ChinaSite Not Available
Changchun University of Chinese Medicine Affiliated Hospital
Changchun, Jilin
ChinaSite Not Available
Tonghua central hospital
Tonghua, Jilin
ChinaSite Not Available
Yan Bian Chao Yi Hospital
Yanbian, Jilin
ChinaSite Not Available
Yanbian University hospital
Yanji, Jilin
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning
ChinaSite Not Available
Yinchuan Peoples Hospital
Yinchuan, Ningxia
ChinaSite Not Available
Zibo central hospital
Zibo, Shandong
ChinaSite Not Available
Linfen Peoples Hospital
Linfen, Shanxi
ChinaSite Not Available
Second hospital of Shanxi Medical University University
Taiyuan, Shanxi
ChinaSite Not Available
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
ChinaSite Not Available
Xidian group hospital
Xi'an, Shanxi
ChinaSite Not Available
Tianjin Peoples Hospital
Tianjing, Tianjing
ChinaSite Not Available
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