The present study was done to assess the safety and effectiveness of Guaifenesin compound pseudoephedrine hydrochloride oral solution (GCPHOS) for the cough, nasal congestion, expectoration, and runny nose treatment in children.

A prospective, randomized, multicentre, single-blind, parallel-controlled clinical trial was conducted. Ten centres had participated in this trial and the actual total number of cases was 412, out of which 205 cases in the trial group were treated with GCPHOS, and 207 cases in the control group were treated with ambroxol hydrochloride oral solution. Both the treatment groups continued for 7 days. The improvement rate of each symptom, the combined symptoms and the overall efficacy rate were compared in the two groups. The adverse drug reactions and compliance were also evaluated.

The treatment of both groups had shown effectiveness except sputum stickiness. The improvement was seen in all symptoms of the trial group and was superior to the control group on the 3^rd day after treatment. Except for nasal congestion, the effectiveness in all the other symptoms in the trial group was improved than in the control group on the 7^th day. The improvement rate for combined symptoms of GCPHOS was 82.9% and the overall effectiveness rate was 89.3%. A higher compliance of GCPHOS was observed and the adverse event rate was only 0.92%.

The trial concluded that GCPHOS exhibited significant safety and effectiveness in children for treatment of cough, nasal congestion, expectoration and runny nose that are caused by common cold or acute tracheobronchitis.

Source: Clinical Research Coordination Group of Guaifenesin Compound Pseudoephedrine Hydrochloride Oral Solution, Lu Q. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution]. Zhonghua Er Ke Za Zhi. 2010 Mar;48(3):204-7. Chinese. PMID: 20426957.