92906
document
Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained-release pseudoephedrine in the management of nasal congestion . BACKGROUND The aim of this study was to assess the clinical efficacy of an oral formulation of cetirizine 5 mg with sustained-release pseudoephedrine ( PSE ) 120 mg relative to placebo in patients with nasal congestion . METHODS Twenty-four patients with perennial rhinitis due to house-dust-mite ( HDM ) allergy were recruited in this crossover study . A treatment period of 1 week , in which cetirizine/PSE was administered twice daily , was followed by a washout period of at least 2 weeks and a further period of 1 week in which the alternative treatment was given to each patient . Immediately after the first dose of each medication ( day 1 ) , nasal congestion and related symptoms were assessed during a 7-h challenge with HDM feces , with the Vienna Challenge Chamber ( VCC ) , to investigate onset of action of the preparation . A second challenge of 3-h duration , carried out at least 12 h after the final dose , was undertaken after 1 week ( mean ) of twice-daily treatment to assess residual effects of the formulation after achievement of steady state . RESULTS The oral formulation of cetirizine/PSE was significantly ( P < 0.001 ) superior to placebo in improving nasal obstruction during both challenges . The improvement in nasal airflow and nasal patency was significantly greater with cetirizine/PSE than with placebo ( P < 0.02 ) . In addition , subjective assessment of nasal symptoms showed that cetirizine/PSE was significantly superior to placebo in both challenges for the sum of nasal obstruction scores ( P < 0.01 ) . Both medications were well tolerated , and no serious adverse events occurred during the study . CONCLUSIONS In this study , cetirizine/PSE relieved nasal congestion and other objective and subjective symptoms to a significantly greater extent than placebo . No serious adverse events occurred , and both regimens were equally well tolerated .
92907
Intervention_Control
placebo
92908
Intervention_Pharmacological
cetirizine
92909
Intervention_Pharmacological
pseudoephedrine
92910
Intervention_Pharmacological
cetirizine
92911
Intervention_Pharmacological
pseudoephedrine
92912
Intervention_Control
placebo
92913
Intervention_Pharmacological
cetirizine/PSE
92914
Intervention_Pharmacological
cetirizine/PSE
92915
Intervention_Control
placebo
92916
Intervention_Pharmacological
cetirizine/PSE
92917
Intervention_Control
placebo
92918
Intervention_Control
placebo
92919
Intervention_Pharmacological
cetirizine/PSE
92920
Outcome_Other
Efficacy
92921
Outcome_Other
safety
92922
Outcome_Physical
management of nasal congestion
92923
Outcome_Other
clinical efficacy
92924
Outcome_Physical
nasal congestion
92925
Outcome_Other
effects
92926
Outcome_Physical
nasal obstruction
92927
Outcome_Physical
nasal airflow
92928
Outcome_Physical
nasal patency
92929
Outcome_Physical
sum of nasal obstruction scores
92930
Outcome_Other
tolerated
92931
Outcome_Adverse-effects
adverse events
92932
Outcome_Physical
nasal congestion
92933
Outcome_Adverse-effects
adverse events
92934
Outcome_Other
tolerated
92935
Participant_Condition
nasal congestion
92936
Participant_Condition
patients with nasal congestion .
92937
Participant_Sample-size
Twenty-four