CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01364467
NCT01364467Phase 2Completed

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

Virginia Commonwealth University·interventional·Posted Jun 2, 2011·Updated Apr 24, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo and Guaifenesin for Chronic Rhinitis. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 5, 2018
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 15.1 years ago

Interventions

Placebodrug

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.

Guaifenesindrug

Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.