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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01364467
First received: May 4, 2011
Last updated: April 10, 2014
Last verified: April 2014
  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:


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: January 2015
Estimated Primary Completion Date: January 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Jennifer L Bradley, B.A.    804-628-2793    jlbradley@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: April 10, 2014
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 July 20, 2014