The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Rhinitis
In brief
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.
Key facts
- Study ID
- NCT01364467
- Run by
- Virginia Commonwealth University
- People needed
- 30
- Starts
- 2011-05-01
- Expected to finish
- 2018-03-05
- Last updated by the study team
- 2020-04-24
Who can join
Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.
You may not qualify if…
- 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.
Where it is running
- Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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