The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
NCT01364467
Last updated date
ABOUT THIS 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 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 Location
Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic
Richmond, Virginia, 23298, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Rhinitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
7-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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.
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Chronic RhinitisThe Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
NCT01364467
- Richmond, Virginia
ALL GENDERS
7 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study | ||||
| Official Title ICMJE | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||
| Condition ICMJE | Chronic Rhinitis | ||||
| Intervention ICMJE |
| ||||
| Study Arms ICMJE |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 30 | ||||
| Original Estimated Enrollment ICMJE | 36 | ||||
| Actual Study Completion Date ICMJE | March 5, 2018 | ||||
| Actual Primary Completion Date | March 5, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 7 Years to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01364467 | ||||
| Other Study ID Numbers ICMJE | HM13538 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Virginia Commonwealth University | ||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Virginia Commonwealth University | ||||
| Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||