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The Effect of Pseudoephedrine on Rhinitis and Sleep

Information source: Penn State University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis; Sleep

Intervention: Pseudoephedrine (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Penn State University

Official(s) and/or principal investigator(s):
Timothy J Craig, D.O., Principal Investigator, Affiliation: Penn State University

Overall contact:
Timothy J Craig, D.O., Phone: 717-531-6525, Email: tcraig@psu.edu

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Improvement of sleep associated with the use of pseudoephedrine as compared to the placebo

Secondary outcome: Improvement of daytime somnolence with pseudoephedrine as compared to placebo

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Timothy J Craig, D.O., Phone: 717-531-6525, Email: tcraig@psu.edu

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Timothy J Craig, D.O., Phone: 717-531-6525, Email: tcraig@psu.edu
Additional Information

Starting date: June 2007
Last updated: June 24, 2008

Page last updated: August 20, 2015

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