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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01364467
Recruitment Status : Recruiting
First Posted : June 2, 2011
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Rhinitis Drug: Placebo Drug: Guaifenesin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Study Start Date : May 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Subjective nasal scoring [ Time Frame: 10 Minutes ]
    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 :
  1. Nasal Volume [ Time Frame: 15 Minutes ]
    Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.

  2. Nasal Secretion Collection [ Time Frame: 10 minutes ]
    To measure the biophysical properties of nasal secretions for improved mucus clearance.

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364467

United States, Virginia
Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic Recruiting
Richmond, Virginia, United States, 23298
Contact: Kelley Dodson, MD    804-828-3965   
Principal Investigator: Kelley Dodson, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Kelley Dodson, M.D. Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT01364467     History of Changes
Other Study ID Numbers: HM13538
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Chlorpheniramine, phenylpropanolamine drug combination
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents