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

NCT01364467

Last updated date
Study Location
Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic
Richmond, Virginia, 23298, United States
Contact
1-800-718-1021

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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
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
  1. 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
  • Drug: Placebo
    Children aged 7-11 years old will receive placebo 200 mg three times a day (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.
Study Arms  ICMJE
  • 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
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
 (submitted: August 22, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kelley Dodson, M.D.Virginia Commonwealth University
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