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

This study is currently recruiting participants.
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

May 4, 2011
April 10, 2014
May 2011
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01364467 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Rhinitis
  • 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.
  • 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.
  • Placebo Comparator: Placebo
    Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
    Intervention: Drug: Placebo
  • Active Comparator: Guaifenesin
    Intervention: Drug: Guaifenesin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
January 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
7 Years to 18 Years
No
Not Provided
United States
 
NCT01364467
HM13538
No
Virginia Commonwealth University
Virginia Commonwealth University
Pfizer
Principal Investigator: Kelley Dodson, M.D. Virginia Commonwealth University
Virginia Commonwealth University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP