[A clinical trial to evaluate the efficacy and safety of compound pseudoephedrine hydrochloride sustained release capsule in patients with seasonal allergic rhinitis].
OBJECTIVE
To evaluate the efficacy and safety of compound pseudoephedrine hydrochloride sustained release capsule (Contac NT) in the relief of symptoms (such as nasal congestion, runny nose, nasal itching, sneezing, watery eyes, ocular itching and ear/palate itching) and signs (such as congested nasal mucosa and conchae, red eyes) in patients with Seasonal Allergic Rhinitis (SAR).


METHODS
An open, multi-centre clinical trial was conducted. Contac NT (one capsule, twice a day, with an interval of 12 hours, successively for 7 days) was given to patients with seasonal allergic rhinitis.


RESULTS
A total of 370 patients were eligible for efficacy analysis, 371 patients were eligible for safety analysis. The symptoms and signs improved significantly after medication, improvement of Day 1 to Day 7 in individual symptom and sign scores was highly statistically significant (P < 0.001). These results were clinically meaningful given that symptoms and signs were "much improved" in 70% and 68% of patients, respectively, "Total improved" rates for symptoms and signs were 89% and 80% respectively. There were 54 patients who reported 61 adverse events. The most frequent were mild to moderate drowsiness and dry mouth. There were no serious adverse events during the study.


CONCLUSIONS
Compound pseudoephedrine hydrochloride sustained release capsule (Contac NT) was effective in controlling SAR symptoms and signs and well tolerated.
D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002214:Capsules; D002744:Chlorpheniramine / Q000008:administration & dosage* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004809:Ephedrine / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D014662:Vasoconstrictor Agents / Q000008:administration & dosage* / Q000627:therapeutic use
D018926:Anti-Allergic Agents; D002214:Capsules; D003692:Delayed-Action Preparations; D014662:Vasoconstrictor Agents; D002744:Chlorpheniramine; D004809:Ephedrine