The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Information source: Virginia Commonwealth University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Rhinitis
Intervention: Placebo (Drug); Guaifenesin (Drug)
Phase: Phase 2
Sponsored by: Virginia Commonwealth University
Official(s) and/or principal investigator(s):
Kelley Dodson, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University
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.
Official title: The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Subjective nasal scoring
Nasal Secretion Collection
Minimum age: 7 Years.
Maximum age: 18 Years.
- Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and
nasal stuffiness for at least 3 month duration.
- Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of
bacterial infection, and/or those who are unable to cooperate with testing will be
excluded. Children with documented use of the study medication in the month before
evaluation and during period of symptoms will also be excluded.
Locations and Contacts
Childern's Hospital of Richmond, Children's Pavilion & Nelson Clinic, Richmond, Virginia 23298, United States; Recruiting
Melissa Yopp, BS, Phone: 804-628-2793, Email: firstname.lastname@example.org
Kelley Dodson, MD, Phone: 804-828-3965, Email: email@example.com
Kelley Dodson, MD, Principal Investigator
Starting date: May 2011
Last updated: June 20, 2012