Phase 3 N=34 Randomized Double-blind Treatment

The Effect of Pseudoephedrine on Rhinitis and Sleep

Rhinitis · Sleep

Bottom Line

View on ClinicalTrials.gov: NCT00704496 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2017

Primary outcome: Primary: Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pseudoephedrine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo	—	—
SECONDARY Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo	—	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 to 65.
History of allergic rhinitis.
The ability to be placed on placebo without significant compromise in the quality of life.
General good health.
Ability to comply with the protocol and sign an informed consent.
Have daytime sleepiness by history.
Have poor sleep by history.
Have fatigue by history.
Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.

Exclusion Criteria

Age fewer than 18 or over 65 years.
A history of sleep apnea.
Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
Non-allergic rhinitis.
Hypertension
Diabetes Mellitus
Inability to tolerate pseudoephedrine
Significant other diseases as determined by the investigator.
Use of a research medication within 30 days.
Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
Excessive use of alcohol or drug abuse.
Inability to stop medication use during run-in period.
Use of an oral antihistamine within 1 week of enrollment.
Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00704496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.