The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of oral guaifenesin for the therapy of Chronic Rhinitis 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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study|
- Subjective nasal scoring [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assess the impact of infection on nasal symptoms, emotion, and activity on a scale of worsening symptoms scored 1 through 7 to provide a quantifiable score capable of comparing both disease severity and the impact of interventions on subjective complaints.
- Nasal Volume [ Time Frame: 15 Minutes ] [ Designated as safety issue: No ]Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
- Nasal Secretion Collection [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]To measure the biophysical properties of nasal secretions for improved mucus clearance.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
Children aged 7-11 years old will receive placebo 200 mg TID, while children older than 12 will receive Placebo 400 mg TID.
|Active Comparator: Guaifenesin||
Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364467
|United States, Virginia|
|Childern's Hospital of Richmond, Children's Pavilion & Nelson Clinic||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Jennifer L Bradley, B.A. 804-628-2793 firstname.lastname@example.org|
|Contact: Kelley Dodson, MD 804-828-3965 email@example.com|
|Principal Investigator: Kelley Dodson, MD|
|Principal Investigator:||Kelley Dodson, M.D.||Virginia Commonwealth University|