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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.
Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic
Richmond, Virginia, United States
Change in Subjective Nasal Scoring
The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assesses the impact of infection on nasal symptoms, emotion, and activity. The SN-5 is a 5-item scale with each item rated on a scale of worsening symptoms from 1 (none of the time) through 7 (all of the time). Items were averaged to yield a single score ranging from 1 (better outcomes) to 7 (worse outcomes). Scores were used to asses change in disease severity and the impact of interventions on subjective complaints from baseline to follow-up.
Time frame: Baseline to 10 Minutes
Nasal Volume
Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
Time frame: 15 Minutes
Nasal Secretion Collection
To measure the biophysical properties of nasal secretions for improved mucus clearance.
Time frame: 10 minutes
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