Phase 2
N=30
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Chronic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01364467 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Subjective Nasal Scoring — 0.62; 1.53 score on a scale — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Guaifenesin (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Subjective Nasal Scoring |
0.62; 1.53 | 0.013 sig |
| SECONDARY Nasal Volume |
1.10; 1.13; 0.83; 1.08 | 0.98 |
| SECONDARY Nasal Secretion Collection |
— | — |
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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01364467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.