The Effect of Pseudoephedrine on Rhinitis and Sleep

Phase 3

Completed

• Conditions: Rhinitis; Sleep
• Interventions: Drug: Pseudoephedrine

• Registration Number: NCT00704496
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2017-09
• Results First Submitted: 2017-09-20
• Results First Submitted QC: 2017-09-20
• Last Update Submitted: 2017-09-20
• Results First Posted: 2017-10-18
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Pseudoephedrine	Placebo
Pseudoephedrine	Pseudoephedrine	Pseudoephedrine is a 240 mg PO per day

Primary Outcome Measures

Name	Time	Method
Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo	3 years	sleep improvement by subjective questionnaires

Secondary Outcome Measures

Name	Time	Method
Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo	3 years	daytime sleepiness by subjective questionnaires

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States