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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01364467|
Recruitment Status : Recruiting
First Posted : June 2, 2011
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinitis||Drug: Placebo Drug: Guaifenesin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 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|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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 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.
- 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.
- 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.
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||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Kelley Dodson, MD 804-828-3965 Kelly.Dodson@vcuhealth.org|
|Principal Investigator: Kelley Dodson, MD|
|Principal Investigator:||Kelley Dodson, M.D.||Virginia Commonwealth University|