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

NCT01364467 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HM13538
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Subjective Nasal Scoring

  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.

  Baseline to 10 Minutes

Secondary Outcomes (2)

• Nasal Volume

  15 Minutes

• Nasal Secretion Collection

  10 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Guaifenesin

ACTIVE COMPARATOR

Drug: Guaifenesin

Interventions

Placebo 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.

Placebo

Guaifenesin DRUG

Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.

Guaifenesin

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Pfizer: collaborator

Study Sites (1)

Virginia Commonwealth University Children's Hospital of Richmond, Children's Pavilion & Nelson Clinic

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Guaifenesin

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Kelley M. Dodson, MD, FACS
• Organization: Virginia Commonwealth University

kelley.dodson@vcuhealth.org

804-828-3965

Study Officials

• Kelley Dodson, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: June 2, 2011
• Study Start: May 1, 2011
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Locations

US (1)