drugset / Trial / NCT01364467

The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study

NCT01364467

Phase 2 Completed 30 enrolled Virginia Commonwealth University Pfizer · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of 7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal airway volume, and biophysical properties of nasal secretion. The investigators hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal volume and cross-sectional area following use of guaifenesin, and nasal secretions will have more favorable mucociliary and sneeze clearability compared to use of placebo.

Timeline

Start
2011-05
Primary completion
2018-03-05
Completion
2018-03-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Guaifenesin Small molecule 200 mg Oral
Comparator Guaifenesin Small molecule 400 mg Oral

Indications