Chronic Rhinitis | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Chronic Rhinitis research study
What is the primary objective of this 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.
Who is eligible to participate?
Inclusion Criteria: - Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration. Exclusion Criteria: - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboChildren aged 7-11 years old will receive placebo 200 mg TID, while children older than 12 will receive Placebo 400 mg TID.
Drug:GuaifenesinChildren aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
Start Date: May 2011
Completed Date: January 2018
Phase: Phase 2
Primary Outcome: Subjective nasal scoring
Secondary Outcome: Nasal Volume
Study sponsors, principal investigator, and references
Principal Investigator: Kelley Dodson, M.D.
Lead Sponsor: Virginia Commonwealth University