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The Effect of Pseudoephedrine on Rhinitis and Sleep

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Penn State University.
Recruitment status was:  Recruiting
Information provided by:
Penn State University Identifier:
First received: June 24, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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.

Condition Intervention
Rhinitis Sleep Drug: Pseudoephedrine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Improvement of sleep associated with the use of pseudoephedrine as compared to the placebo [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Improvement of daytime somnolence with pseudoephedrine as compared to placebo [ Time Frame: 3 years ]

Estimated Enrollment: 32
Study Start Date: June 2007
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00704496

Contact: Timothy J Craig, D.O. 717-531-6525

United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Timothy J Craig, D.O.    717-531-6525   
Sponsors and Collaborators
Penn State University
Principal Investigator: Timothy J Craig, D.O. Penn State University
  More Information

Responsible Party: Timothy Craig, D.O., Penn State University Identifier: NCT00704496     History of Changes
Other Study ID Numbers: 25325
Study First Received: June 24, 2008
Last Updated: June 24, 2008

Keywords provided by Penn State University:
Sleep, Pseudoephedrine

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017