runny nose caused by colds
Conditions
Interventions
group of 160µg dose:patients receive 160µg each time
group of 320µg dose:patients receive 320µg each time
group of placebo:patients receive 0µg each time
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-65 years old (including boundary value), males and females will be accepted; 2) The patients are clinically diagnosed as acute upper respiratoing infection and have cold less than 48 hours. During the screening period, the VAS score of runny nose symptoms are = 4.0; 3) Be able to cooperate with the investigator to administer drugs in nasal cavity; 4) Before the study, the patient fully understand the study content, process and the possible adverse drug reactions (ADRs), and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients are allergic to the research drug or its components; 2) patients who cannot tolerate intranasal administration in the past; 3) Patients have acute bacterial rhinitis, nasosinusitis (fever with purulent mucus, increased white blood cell count in peripheral blood), allergic rhinitis (with a history of allergic rhinitis); 4) Patients with history of glaucoma, cataract, prostatitis and/or Benign prostatic hyperplasia and bladder neck obstruction; 5) Other significant bronchial and pulmonary diseases, including lower respiratory tract infection and asthma; 6) Pantients with common complications related to upper respiratory tract infection, such as laryngitis, bronchitis, otitis media, etc; 7)Patients with nasal abnormalities that affected drug administration in the screening period; 8)Patients who had nose and eyeball injury or surgery within 3 months before screening; 9)Patients with serious liver and kidney diseases, or abnormal liver and kidney functions (ALT, AST = 2 times of the upper limit of normal value, or Cr>1.5 times of the upper limit of normal value); patients with abnormal cardiac function (CK-MB exceeds the range of normal value, or CK = 2 times of the upper limit of normal value); 10) Drug abusers or drug addicts; 11) Patients who stop taking the following drugs for less than 24 hours or plan to use the following drugs or/and treatments during the study period: a.CYP2D6 inducers and inhibitors, such as amiodarone, amitriptyline, bupropion, celecoxib, etc; b. Leukotriene Modifiers (Montelukast, etc); c. Antihistamines (including loratadine, cetirizine, ebastine, and compound cold preparations containing chlorpheniramine maleate; except for rescue drugs required during the trial); d. Leukotriene regulator (including montelukast, etc.); e. stabilizer of the mast cell membrane (including sodium cromoglycate, nedocromil sodium, AA-344, nedoromide sodium, Pemirolast Potassium and tranilast, etc.); f. decongestant drug (including Ephedrine Hydrichloride and Oxymetazoline, Xylometazoline and cold preparations containing pseudoephedrine); g. anticholinergic activity (including ipratropium bromide, tiotropium bromide, Glycopyrrolate Bromide, etc.); h. immunotherapy drug (including cyclophosphamide, azathioprine, Mycophenolate Mofetil, and anti TNF- a Monoclonal antibody and other drugs); i. Anti allergic Chinese herbal medicine (including Tuckahoe, peony, honeysuckle, skullcap, Chinese prickly ash, wormwood leaf, forsythia, licorice, Kochia scoparia, etc.); 12) Patients who had participated in clinical trials of other drugs or medical devices within 30 days before screening, or plan to participate in clinical trials of other drugs or medical devices; 13) Women who are pregnant, lactating or planning to be pregnant in the near future; Or whose pregnancy test are positive before enrollment; 14) Males (or their partners) or females have pregnancy plans or sperm/egg donation plans during the whole trial period and within 6 months after the end of the study, or are unwilling to take contraceptive measures; 15) Patients who cannot independently complete VAS scoring; 16) According to the judgment of the researcher, subjects who may have an impact on the compliance of any aspect of the study (including the completion of the visit plan and diary card or questionnaire) due to physical, cultural level or geographical location; 17)Investigators estimate patients that there are other reasons are not suitable for enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity score (VAS) of runny nose - area under the time curve (the period from before administration to the completion of 96h administration); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change of respective VAS score of runny nose, stuffy nose and sneezing from baseline every 24h;Mean change in the total VAS score of runny nose, stuffy nose and sneezing from baseline every 24 hours;Stuffy nose and sneezing symptom severity score - area under the time curve (the period from before administration to the completion of 96h administration);Mean change of respective VAS score of runny nose, stuffy nose and sneezing from baseline within 48 hours after the first administration;Mean change of total VAS score of runny nose, sneezing and stuffy nose from baseline within 48 hours after the first administration; | — |
Countries
China
Contacts
Public ContactShen Ning
Peking University Third Hospital
Outcome results
None listed