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NCT01364467 · ClinicalTrials.gov registry record · Phase 2
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
A Phase 2 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01364467: Completed Phase 2 study, sponsored by Virginia Commonwealth University.
NCT01364467 is a Phase 2 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364467, a Phase 2 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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 t
Interventions
- DRUG Placebo
- DRUG Guaifenesin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-05 |
| Est. Completion | 2018-03-05 |
| Phase | Phase 2 |
What the finished NCT01364467 record still lists
NCT01364467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01364467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01364467 about?
NCT01364467 is a clinical study titled "The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study". 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...
What is the current status of trial NCT01364467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-05. Estimated completion is 2018-03-05.
What interventions are being tested in trial NCT01364467?
The interventions under investigation include: Placebo (DRUG), Guaifenesin (DRUG).
Who is sponsoring clinical trial NCT01364467?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01364467's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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