Trial Outcomes & Findings for The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study (NCT NCT01364467)
NCT ID: NCT01364467
Last Updated: 2020-04-24
Results Overview
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.
COMPLETED
PHASE2
30 participants
Baseline to 10 Minutes
2020-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
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
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 Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
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
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 Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
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
n=20 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.75 years
STANDARD_DEVIATION 2.99 • n=99 Participants
|
10.35 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
10.46 years
STANDARD_DEVIATION 2.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
20 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 MinutesThe 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.
Outcome measures
| Measure |
Placebo
n=9 Participants
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
n=18 Participants
Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
|
|---|---|---|
|
Change in Subjective Nasal Scoring
|
0.62 score on a scale
Standard Deviation 0.59
|
1.53 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 15 MinutesAcoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
Outcome measures
| Measure |
Placebo
n=9 Participants
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
n=18 Participants
Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
|
|---|---|---|
|
Nasal Volume
Right nostril
|
1.10 Square centimeters
Standard Deviation 0.4
|
1.13 Square centimeters
Standard Deviation 0.66
|
|
Nasal Volume
Left nostril
|
0.83 Square centimeters
Standard Deviation 0.44
|
1.08 Square centimeters
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: Unable to analyze due to insufficient sample material
To measure the biophysical properties of nasal secretions for improved mucus clearance.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Guaifenesin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelley M. Dodson, MD, FACS
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place