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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

Status: Recruiting

Sponsored by: Virginia Commonwealth University

Official(s) and/or principal investigator(s):
Kelley Dodson, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University

Summary

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.

Clinical Details

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

Secondary outcome:

Nasal Volume

Nasal Secretion Collection

Eligibility

Minimum age: 7 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

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: mayopp@vcu.edu
Kelley Dodson, MD, Phone: 804-828-3965, Email: kdodson@mcvh-vcu.edu
Kelley Dodson, MD, Principal Investigator
Additional Information

Starting date: May 2011
Last updated: June 20, 2012

Page last updated: February 07, 2013

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