Clinical trial NCT00704496: The Effect of Pseudoephedrine on Rhinitis and Sleep
Official title: The Effect of Pseudoephedrine on Rhinitis and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Sleep
Keywords: Sleep, Pseudoephedrine
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
timeFrame: 3 years
Secondary outcomes:
measure: Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo
timeFrame: 3 years
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Timothy J Craig, D.O.
role: PRINCIPAL_INVESTIGATOR
References: