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The Effect of Pseudoephedrine on Rhinitis and Sleep
This study is currently recruiting participants.
Verified by Penn State University, June 2008
Sponsored by: Penn State University
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00704496
  Purpose

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

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of daytime somnolence with pseudoephedrine as compared to placebo [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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: Placebo Comparator
Placebo
Drug: Placebo
Pseudoephedrine: Active Comparator
Pseudoephedrine is a 240 mg PO per day
Drug: Pseudoephedrine
Pseudoephedrine is a 240 mg PO per day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704496

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

Locations
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     tcraig@psu.edu    
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Timothy J Craig, D.O. Penn State University
  More Information

Responsible Party: Penn State University ( Timothy Craig, D.O. )
Study ID Numbers: 25325, 25325
Study First Received: June 24, 2008
Last Updated: June 24, 2008
ClinicalTrials.gov Identifier: NCT00704496  
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Sleep, Pseudoephedrine

Study placed in the following topic categories:
Naphazoline
Pseudoephedrine
Oxymetazoline
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Guaifenesin
Phenylephrine
Ephedrine
Rhinitis
Phenylpropanolamine

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents
Nose Diseases
Pharmacologic Actions
Nasal Decongestants
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009