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[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].

Abstract

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.

METHOD

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.

CONCLUSION

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.

Authors+Show Affiliations

,

Guangzhou Institute of Respiratory Disease, Guangzhou Medical College, Guangzhou 510120, China.

Source

Zhonghua nei ke za zhi 41:8 2002 Aug pg 547-9

MeSH

Adolescent
Adult
Aged
Common Cold
Delayed-Action Preparations
Female
Humans
Influenza, Human
Male
Middle Aged
Nasal Decongestants
Nasal Obstruction
Phenylpropanolamine
Sleep Wake Disorders
Sneezing
Treatment Outcome
Xerostomia

Pub Type(s)

Clinical Trial
English Abstract
Journal Article
Multicenter Study

Language

chi

PubMed ID

12421505

Citation

New Contac Multi-Center Clinical Cooperative Group, , and Zhenglun Xiao. "[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]." Zhonghua Nei Ke Za Zhi, vol. 41, no. 8, 2002, pp. 547-9.
New Contac Multi-Center Clinical Cooperative Group , Xiao Z. [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]. Zhonghua Nei Ke Za Zhi. 2002;41(8):547-9.
New Contac Multi-Center Clinical Cooperative Group, ., & Xiao, Z. (2002). [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]. Zhonghua Nei Ke Za Zhi, 41(8), pp. 547-9.
New Contac Multi-Center Clinical Cooperative Group , Xiao Z. [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]. Zhonghua Nei Ke Za Zhi. 2002;41(8):547-9. PubMed PMID: 12421505.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [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]. AU - New Contac Multi-Center Clinical Cooperative Group,, AU - Xiao,Zhenglun, PY - 2002/11/8/pubmed PY - 2003/2/6/medline PY - 2002/11/8/entrez SP - 547 EP - 9 JF - Zhonghua nei ke za zhi JO - Zhonghua Nei Ke Za Zhi VL - 41 IS - 8 N2 - 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. METHOD: 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. CONCLUSION: 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. SN - 0578-1426 UR - https://www.unboundmedicine.com/medline/citation/12421505/[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]_ L2 - https://medlineplus.gov/coldandcoughmedicines.html DB - PRIME DP - Unbound Medicine ER -