NCT00704496

The Effect of Pseudoephedrine on Rhinitis and Sleep

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Detailed description

The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.

Conditions

• Rhinitis
• Sleep

Interventions

Type	Name	Description
DRUG	Pseudoephedrine	Pseudoephedrine is a 240 mg PO per day

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-06-25
• Last updated: 2017-10-18
• Results posted: 2017-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study