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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinitis||Drug: Placebo Drug: Guaifenesin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 5, 2018|
|Actual Study Completion Date :||March 5, 2018|
Placebo Comparator: Placebo
Placebo is provided by the sponsor and is identical in composition to the treatment only lacking active drug.
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.
|Active Comparator: 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 [ 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364467
|United States, Virginia|
|Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Kelley Dodson, M.D.||Virginia Commonwealth University|