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

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ClinicalTrials.gov Identifier: NCT01364467
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE May 4, 2011
First Posted Date  ICMJE June 2, 2011
Results First Submitted Date  ICMJE April 2, 2020
Results First Posted Date  ICMJE April 24, 2020
Last Update Posted Date April 24, 2020
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
Change in Subjective Nasal Scoring [ Time Frame: Baseline to 10 Minutes ]
The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assesses the impact of infection on nasal symptoms, emotion, and activity. The SN-5 is a 5-item scale with each item rated on a scale of worsening symptoms from 1 (none of the time) through 7 (all of the time). Items were averaged to yield a single score ranging from 1 (better outcomes) to 7 (worse outcomes). Scores were used to asses change in disease severity and the impact of interventions on subjective complaints from baseline to follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • 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.
  • Nasal Secretion Collection [ Time Frame: 10 minutes ]
    To measure the biophysical properties of nasal secretions for improved mucus clearance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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