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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2

Conditions: Chronic Rhinitis

Treatments: Drug: Guaifenesin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01364467

HM13538

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.

Treatment:

Drug: Placebo

Guaifenesin

Active Comparator group

Treatment:

Drug: Guaifenesin