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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. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Rhinitis
Interventions Drug: Placebo
Drug: Guaifenesin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Guaifenesin
Hide Arm/Group Description

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Period Title: Overall Study
Started 10 20
Completed 9 18
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title Placebo Guaifenesin Total
Hide Arm/Group Description

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID. Total of all reporting groups
Overall Number of Baseline Participants 10 20 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 20 participants 30 participants
10.75  (2.99) 10.35  (2.9) 10.46  (2.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
5
  50.0%
9
  45.0%
14
  46.7%
Male
5
  50.0%
11
  55.0%
16
  53.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  20.0%
0
   0.0%
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  40.0%
11
  55.0%
15
  50.0%
White
2
  20.0%
6
  30.0%
8
  26.7%
More than one race
2
  20.0%
3
  15.0%
5
  16.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 20 participants 30 participants
10 20 27
1.Primary Outcome
Title Change in Subjective Nasal Scoring
Hide Description 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.
Time Frame Baseline to 10 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Guaifenesin
Hide Arm/Group Description:

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Overall Number of Participants Analyzed 9 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.62  (0.59) 1.53  (1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Guaifenesin
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Nasal Volume
Hide Description Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
Time Frame 15 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Guaifenesin
Hide Arm/Group Description:

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Overall Number of Participants Analyzed 9 18
Mean (Standard Deviation)
Unit of Measure: Square centimeters
Right nostril 1.10  (0.4) 1.13  (0.66)
Left nostril 0.83  (0.44) 1.08  (0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guaifenesin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Nasal Secretion Collection
Hide Description To measure the biophysical properties of nasal secretions for improved mucus clearance.
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to analyze due to insufficient sample material
Arm/Group Title Placebo Guaifenesin
Hide Arm/Group Description:

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Guaifenesin
Hide Arm/Group Description

Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active 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.

Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
All-Cause Mortality
Placebo Guaifenesin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
Placebo Guaifenesin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Guaifenesin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kelley M. Dodson, MD, FACS
Organization: Virginia Commonwealth University
Phone: 804-828-3965
EMail: kelley.dodson@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01364467    
Other Study ID Numbers: HM13538
First Submitted: May 4, 2011
First Posted: June 2, 2011
Results First Submitted: April 2, 2020
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020