The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
This study is currently recruiting participants.
Verified June 2012 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
Collaborator:
Pfizer
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01364467
First received: May 4, 2011
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of oral guaifenesin for the therapy of Chronic Rhinitis 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Rhinitis |
Drug: Placebo Drug: Guaifenesin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study |
Resource links provided by NLM:
Drug Information available for:
Guaifenesin
Phenylpropanolamine hydrochloride
Triaminic
Phenylpropanolamine
U.S. FDA Resources
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- Subjective nasal scoring [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assess the impact of infection on nasal symptoms, emotion, and activity on a scale of worsening symptoms scored 1 through 7 to provide a quantifiable score capable of comparing both disease severity and the impact of interventions on subjective complaints.
Secondary Outcome Measures:
- Nasal Volume [ Time Frame: 15 Minutes ] [ Designated as safety issue: No ]Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
- Nasal Secretion Collection [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]To measure the biophysical properties of nasal secretions for improved mucus clearance.
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
|
Drug: Placebo
Children aged 7-11 years old will receive placebo 200 mg TID, while children older than 12 will receive Placebo 400 mg TID.
|
| Active Comparator: Guaifenesin |
Drug: Guaifenesin
Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
|
Eligibility| Ages Eligible for Study: | 7 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364467
Locations
| United States, Virginia | |
| Childern's Hospital of Richmond, Children's Pavilion & Nelson Clinic | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Melissa Yopp, BS 804-628-2793 mayopp@vcu.edu | |
| Contact: Kelley Dodson, MD 804-828-3965 kdodson@mcvh-vcu.edu | |
| Principal Investigator: Kelley Dodson, MD | |
Sponsors and Collaborators
Virginia Commonwealth University
Pfizer
Investigators
| Principal Investigator: | Kelley Dodson, M.D. | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01364467 History of Changes |
| Other Study ID Numbers: | HM13538 |
| Study First Received: | May 4, 2011 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Guaifenesin Phenylpropanolamine Chlorpheniramine, phenylpropanolamine drug combination Expectorants Respiratory System Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013