[An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine [corrected] hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold].
OBJECTIVE
To evaluate the efficacy and safety of compound pseudoephedrine [corrected] hydrochloride (New Contact sustained release capsules) in the treatment of the nasal symptoms associated with common cold or influenza.


METHODS
Open label multi-center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza.


RESULTS
A total of 416 patients were eligible for efficacy and safety analysis. The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study. Forty adverse events (AE's) with an incidence of 8% were developed in 35 patients. The most frequent AE's were drowsiness (24/416, 6%) and dry mouth (5/416, 1%). All AE's were in mild or moderate degree.


CONCLUSIONS
The results indicated that New Contact sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well-tolerated.
New Contac Multi-Center Clinical Cooperative Group
Guangzhou Institute of Respiratory Disease, Guangzhou Medical College, Guangzhou 510120, China.
Xiao
Zhenglun
Z
D000293:Adolescent; D000328:Adult; D000368:Aged; D003139:Common Cold / Q000150:complications / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007251:Influenza, Human / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000009:adverse effects / Q000627:therapeutic use*; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D010665:Phenylpropanolamine / Q000009:adverse effects / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000139:chemically induced; D012912:Sneezing / Q000187:drug effects; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced
D003692:Delayed-Action Preparations; D014663:Nasal Decongestants; D010665:Phenylpropanolamine