The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: No
View:

• Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.

Locations
United States
Virginia
Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic
Richmond
Time Frame
Start Date: May 2011
Completion Date: March 5, 2018
Participants
Target number of participants: 30
Treatments
Placebo Comparator: Placebo
Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
Active Comparator: Guaifenesin
Authors
Kelley Dodson
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov

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