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

Phase 2

Completed

• Conditions: Chronic Rhinitis
• Interventions: Drug: Placebo; Drug: Guaifenesin

• Registration Number: NCT01364467
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-02
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Disposition First Submitted: 2019-07-15
• Disposition First Submitted QC: 2019-08-22
• Disposition First Posted: 2019-08-28
• Status Verified: 2020-04
• Results First Submitted: 2020-04-02
• Results First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
Guaifenesin	Guaifenesin	-

Primary Outcome Measures

Name	Time	Method
Change in Subjective Nasal Scoring	Baseline to 10 Minutes	The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assesses the impact of infection on nasal symptoms, emotion, and activity. The SN-5 is a 5-item scale with each item rated on a scale of worsening symptoms from 1 (none of the time) through 7 (all of the time). Items were averaged to yield a single score ranging from 1 (better outcomes) to 7 (worse outcomes). Scores were used to asses change in disease severity and the impact of interventions on subjective complaints from baseline to follow-up.

Secondary Outcome Measures

Name	Time	Method
Nasal Volume	15 Minutes	Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
Nasal Secretion Collection	10 minutes	To measure the biophysical properties of nasal secretions for improved mucus clearance.

Trial Locations

Locations (1)

Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic; 🇺🇸 Richmond, Virginia, United States