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

Chronic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364467
• Other study ID #: HM13538
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: March 5, 2018

Study information

• Verified date: April 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Drug:
• Placebo
Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.
• Guaifenesin
Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Subjective Nasal Scoring	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.	Baseline to 10 Minutes
Secondary	Nasal Volume	Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.	15 Minutes
Secondary	Nasal Secretion Collection	To measure the biophysical properties of nasal secretions for improved mucus clearance.	10 minutes